Regulatory Focus™ > News Articles > Focus' Federal Register Tracking Tool for the Life Science Industry (Updated 25 July 2013)

Focus' Federal Register Tracking Tool for the Life Science Industry (Updated 25 July 2013)

Posted 25 July 2013 | By Alexander Gaffney, RAC

Notice: This page is no longer being updated. The Federal Register Tracking Tool can now be found at the following link, where it is updated regularly: http://www.raps.org/focus-online/federal-register-tracking-tool.aspx


Here at Regulatory Focus, we read the US government's Federal Register like some people check their Facebook pages, which is to say obsessively. When it comes to keeping track of what the US Food and Drug Administration (FDA) is doing - from regulations, to guidance documents, to new programs and general changes - there's just no other place to go.

That being said, keeping track of everything can be extremely difficult, particularly for busy professionals. FDA's documents are sometimes hard to decipher, with information often buried deep within a seemingly obscure notice. Other times a document is extremely long, and you need to figure out what (if anything) is relevant to your professional interests. In still other instances, a seemingly clear document may have more impactful policy implications than is at first evident.

Those challenges are at the heart of what Regulatory Focus deals with every day. Our aim is to make sense of regulatory policy development to keep you informed, allowing regulatory professionals to do their jobs more efficiently and to notice key points they might not otherwise.

The Federal Register Tracking Tool

We're pleased today to unveil a new tracking tool we're calling the Federal Register Tracking Tool, a collection of all the Federal Register notices that are relevant to the life sciences industry, organized by date, general topic and subject area.

Our tool also has three useful features we think you'll find invaluable.

  • First, we have a link to the source Federal Register documentation for each document so you can quickly find all relevant statutory information or submit comments to FDA.
  • Second, we have a link to the source guidance document where available. We know FDA's website can be nearly impossible to navigate, and we hope this will become a useful, expedited shortcut in the future.
  • Third, if we have written an article about a particular Federal Register document, we have included a link to it next to the Register document. We hope this will allow our users to quickly be able to identify important topics and to gather insightful information about a given Register posting.

We plan to update this resource several times per month, so please check back often.

Scroll Down to see the Federal Register Tracking Tool
















Date

Federal Register (FR) Document Title

In Focus

FR Link

Document Type

Product Type

3 January

Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Drugs Product Applications and Related Submissions Using the eCTD Specifications

Here

Here

Guidance

Drugs

4 January

Advisory Committee for Reproductive Health Drugs

Here

Meeting

Drugs

4 January

Medical Imaging Drugs Advisory Committee

Here

Meeting

Medical Device

4 January

Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Here

PMA Update

Medical Device

4 January

Accessible Medical Device Labeling in a Standard Content and Format

Here

Here

Meeting

Medical Device

4 January

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Withdrawal

Here

Here

OMB Collection

Medical Device

7 January

Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Pulmonary/Cardiac Support

Here

Here

Reclassification

Medical Device

7 January

Cardiovascular Devices; Reclassification of External Cardiac Compressor

Here

Here

Reclassification

Medical Device

9 January

Privacy Act, Exempt Record System; Withdrawal

Here

Here

Regulation

General

9 January

Privacy Act, Exempt Record System; Withdrawal

Here

Here

Regulation

General

10 January

Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant

Here

Here

Reclassification

Medical Device

10 January

Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling

Here

Here

Guidance

Drugs

10 January

Blood Products Advisory Committee

Here

Here

Meeting

Blood Product

10 January

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee

Here

Meeting

Drugs

13 January

Modifications to the List of Recognized Standards, Recognition List Number: 030

Here

Here

Standards

Medical Device

13 January

Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need

Here

Here

Meeting

Drugs

16 January

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submission of Food and Drug Administration Adverse Event Reports and Other Safety Information Using the Electronic Submission Gateway and the Safety Reporting Portal

Here

OMB Collection

General

17 January

Generic Drug User Fee-Active Drugs Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year

Here

Here

Administrative

Drugs

18 January

Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices

Here

Here

Reclassification

Medical Device

18 January

Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements

Here

OMB Collection

Supplement

22 January

Current Good Manufacturing Practice Requirements for Combination Products

Here

Here

Regulation

Combination Product

22 January

Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Here

Administrative

Supplement

22 January

Draft Guidance for Industry and Food and Drug Administration Staff; Submissions for Postapproval Modifications to a Combination Product Approved Under Certain Marketing Applications

Here

Here

Guidance

Combination Product

22 January

Electronic Submission Process for Requesting Export Certificates From the Center for Devices and Radiological Health

Here

Here

Administrative

Medical Device

24 January

Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations

Here

Here

Guidance

Medical Device

24 January

Clinical Flow Cytometry in Hematologic Malignancies

Here

Meeting

Medical Device

25 January

Ophthalmic Devices; Classification of the Scleral Plug

Here

Reclassification

Medical Device

25 January

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008

Here

Here

OMB Collection

Drugs

25 January

Vaccines and Related Biological Products Advisory Committee

Here

Meeting

Biologic

28 January

New Animal Drugs; Cefpodoxime; Meloxicam

Here

Administrative

Veterinary

28 January

 Assuring Radiation Protection

Here

Here

Administrative

Medical Device

28 January

Electronic Study Data Submission; Data Standard Support End Date

Here

Here

Administrative

Drugs

28 January

Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling

Here

Here

Guidance

Drugs

28 January

Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It?

Here

Here

Meeting

Drugs

29 January

Statement of Organization, Functions, and Delegations of Authority

Here

Administrative

Veterinary

30 January

Science Board to the Food and Drug Administration

Here

Here

Meeting

General

31 January

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification

Here

AICA

Medical Device

31 January

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program

Here

AICA

Medical Device

31 January

Determination That DIFFERIN (Adapalene) Solution, 0.1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Here

Administrative

Drugs

31 January

Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis

Here

Here

Meeting

General

31 January

Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments; Correction

Here

Administrative

General

31 January

Determination of Regulatory Review Period for Purposes of Patent Extension; BEYAZ

Here

Administrative

Drugs

31 January

Determination of Regulatory Review Period for Purposes of Patent Extension; XALKORI

Here

Administrative

Drugs

4 February

International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of Pharmaceutical

Here

Here

Guidance

Drugs

4 February

Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment Period

Here

Guidance

Drugs, Biologic

6 February

Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement Initiative

Here

Here

Administrative

Drugs

6 February

Training Program for Regulatory Project Managers

Here

Here

Administrative

Drugs

6 February

Medical Device User Fee Cover Sheet, Form FDA 3601

Here

Administrative

Medical Device

6 February

Administrative Detention and Banned Medical Devices

Here

Administrative

Medical Device

7 February

Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis

Here

Reclassification

Medical Device

7 February

Request for Nominations for Voting Members on Public Advisory Panels or Committees

Here

Here

Meeting

Medical Device

8 February

Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight

Here

Reclassification

Medical Device

8 February

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

Here

AICA

General

8 February

Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease

Here

Here

Guidance

Drugs

8 February

International Drug Scheduling; Convention on Psychotropic Substances; World Health Organization Scheduling Recommendations for Gamma-hydroxybutyric Acid

Here

Here

Administrative

Drugs

11 February

Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products

Here

Here

Guidance

Drugs, Biologic

11 February

Food and Drug Administration/Xavier University PharmaLink Conference-Quality in a Global Supply Chain

Here

Meeting

Drugs

12 February

Food and Drug Administration Drug Shortages Task Force and Strategic Plan

Here

Here

Administrative

Drugs

13 February

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes

Here

AICA

Medical Device

13 February

Documents To Support Submission of an Electronic Common Technical Document

Here

Here

Administrative

Drugs

13 February

Annual Computational Science Symposium; Conference

Here

Meeting

Drugs

13 February

Global Quality Systems-An Integrated Approach To Improving Medical Product Safety

Here

Meeting

General

15 February

Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers: Accreditation and Reaccreditation Process for Firms Under the Third Party Review Program: Part I

Here

Here

Guidance

Medical Device

15 February

Guidance for Industry and Food and Drug Administration Staff: Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation

Here

Here

Guidance

Medical Device

15 February

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

Medical Device

15 February

Transmissible Spongiform Encephalopathies Advisory Committee

Here

Meeting

Blood Product

19 February

Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure

Here

Here

Regulation

Medical Device

19 February

Agency Information Collection Activities; Proposed Collection; Comment Request; Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act

Here

Here

AICA

Drugs, Biologic

19 February

Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act

Here

Here

Guidance

Medical Device

19 February

Neonatal Subcommittee of the Pediatric Advisory Committee

Here

Meeting

General

20 February

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations

Here

AICA

General

21 February

Extreme Weather Effects on Medical Device Safety and Quality

Here

Here

Administrative

Medical Device

21 February

Device Good Manufacturing Practice Advisory Committee

Here

Here

Meeting

Medical Device

22 February

Draft Guidance for Industry and Food and Drug Administration Staff: Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements

Here

Here

Guidance

Medical Device

22 February

Determination of Regulatory Review Period for Purposes of Patent Extension; Sapien Transcatheter Heart Valve

Here

Administrative

Medical Device

22 February

Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels

Here

Here

Administrative

General

25 February

Fecal Microbiota for Transplantation

Here

Here

Meeting

Biologic

25 February

Pediatric Advisory Committee

Here

Meeting

Drugs

25 February

Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee

Here

Meeting

Biologic

25 February

Guidance for Industry: Guidance on the Labeling of Certain Uses of Lecithin Derived From Soy Under Section 403(w) of the Federal Food, Drug, and Cosmetic Act; Withdrawal of Guidance

Here

Guidance

Supplement

25 February

Guidance for Industry on Labeling for Human Prescription Drug and Biological Products-Implementing the Physician Labeling Rule Content and Format Requirements

Here

Here

Guidance

Drugs

25 February

Draft Guidance for Industry on Attachment to Guidance on Antiviral Product Development-Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting Hepatitis C Virus Resistance Data

Here

Here

Guidance

Drugs

25 February

Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

Here

Here

Regulation

Medical Device

26 February

Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products

Here

Regulation

General

26 February

Agency Information Collection Activities: Proposed Collection; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application

Here

AICA

Drugs

26 February

Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis

Here

Here

Guidance

Blood Product

26 February

Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators

Here

Here

Guidance

General

26 February

Guidance for Industry: Implementation of an Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma

Here

Here

Guidance

Blood Product

26 February

Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-

Here

Meeting

General

27 February

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

Medical Device

27 February

Oncologic Drugs Advisory Committee

Here

Meeting

Drugs

27 February

Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

Medical Device

27 February

Psychopharmacologic Drugs Advisory Committee

Here

Meeting

Drugs

27 February

Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice

Here

Meeting

General

28 February

Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling

Here

Here

Guidance

Drugs

28 February

Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements

Here

AICA

Medical Device

28 February

Determination of Regulatory Review Period for Purposes of Patent Extension; LAVIV

Here

Administrative

Biologic

28 February

Determination of Regulatory Review Period for Purposes of Patent Extension; ZYTIGA

Here

Administrative

Drugs

4 March

Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff

Here

Here

Guidance

Medical Device

4 March

Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

Here

Regulation

Medical Device

4 March

Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

Here

Regulation

Medical Device

4 March

Determination That GEREF (Sermorelin Acetate) Injection, 0.5 Milligrams Base/Vial and 1.0 Milligrams Base/Vial, and GEREF (Sermorelin Acetate) Injection, 0.05 Milligrams Base/Amp, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Here

Administrative

Drugs

5 March 2913

Draft Guidance for Industry and Food and Drug Administration Staff; Types of Communication During the Review of Medical Device Submissions

Here

Here

Guidance

Medical Device

5 March 2913

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Revised Guidance for Industry on "Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing" (VICH GL23(R))

Here

Guidance

Veterinary

5 March 2913

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on "Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach To Establish a Microbiological Acceptable Daily Intake (ADI)" (VICH GL36(R))

Here

Guidance

Veterinary

6 March

Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food;

Here

Administrative

Supplement

6 March

Cheng Yi Liang: Debarment Order

Here

Here

Administrative

General

6 March

Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses

Here

Here

Guidance

Medical Device

7 March

New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N

Here

Administrative

Veterinary

7 March

Veterinary Oversight of Antimicrobial Use in Livestock: Impact on Stakeholders

Here

Meeting

Veterinary

7 March

Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications

Here

Administrative

Veterinary

8 March

Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide

Here

Guidance

 Supplement

8 March

Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan

Here

Administrative

Drugs

11 March

Draft Guidance for Industry and Food and Drug Administration Staff: Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex

Here

Here

Guidance

Medical Device

11 March

Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis

Here

Here

Meeting

Drugs

12 March

Cellular, Tissue and Gene Therapies Advisory Committee

Here

Meeting

Biologic

13 March

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses

Here

AICA

Biologic

13 March

Cooperative Agreement To Support Regulatory Research Related to Food and Drug Administration Commitments Under the 2012 Prescription Drug User Fee Act

Here

Here

Administrative

Drugs

13 March

Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the Division Level

Here

Here

Guidance

Drugs

13 March

Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation

Here

Here

Guidance

Drugs

13 March

Food and Drug Administration/Xavier University Global Medical Device Conference

Here

Meeting

Medical Device

14 March

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee

Here

Meeting

Biologic

15 March

Institutional Review Boards; Correcting Amendments

Here

Regulation

15 March

Application of Advances in Nucleic Acid and Protein Based Detection Methods to Multiplex Detection of Transfusion-Transmissible Agents and Blood Cell Antigens in Blood Donations

Here

Here

Meeting

General

18 March

Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k)] Submissions

Here

AICA

Medical Device

18 March

Center for Drug Evaluation and Research Medical Policy Council

Here

Here

Administrative

General

18 March

International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of Pharmaceutical

Here

Administrative

Drugs

18 March

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

Medical Device

18 March

Impax Laboratories, Inc.; Withdrawal of Approval of Bupropion Hydrochloride Extended-Release Tablets, 300 Milligrams

Here

Here

Administrative

Drugs

20 March

Public Hearing Before a Public Advisory Committee; Technical Amendments

Here

Regulation

General

20 March

Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs

Here

AICA

Drugs

21 March

Pulmonary-Allergy Drugs Advisory Committee

Here

Meeting

Drugs

21 March

Risk Communications Advisory Committee

Here

Here

Meeting

General

21 March

Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Here

PMA Update

Medical Device

22 March

New Animal Drugs; Changes of Sponsor

Here

Administrative

Veterinary

22 March

Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases

Here

Here

Administrative

Drugs

25 March

New Animal Drug Approvals; Change of Sponsor; Change of Sponsor's Drug Labeler Code; Gonadorelin Acetate; Isoflurane; Praziquantel; Propofol; Sevoflurane; Triamcinolone Acetonide

Here

Administrative

Veterinary

25 March

Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System

Here

Here

Regulation

Medical Device

25 March

Determination That BENADRYL (diphenhydramine hydrochloride) Injection and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Here

Administrative

Drugs

25 March

Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Extension of Comment Period

Here

Meeting

Medical Device

26 March

Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United States; Agent Designation; Change of Address

Here

Administrative

Medical Device

26 March

Medical Devices; Technical Amendment

Here

Administrative

Medical Device

26 March

Food Labeling; Notification Procedures for Statements on Dietary Supplements

Here

Administrative

Supplement

26 March

Determination That QUESTRAN (Cholestyramine for Oral Suspension, USP), Equivalent to 4 Grams, and QUESTRAN LIGHT (Cholestyramine for Oral Suspension, USP), Equivalent to 4 Grams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Here

Administrative

Drugs

26 March

Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability

Here

Here

Guidance

Blood Product

27 March

Summit on Color in Medical Imaging; Cosponsored Public Workshop; Request for Comments

Here

Here

Meeting

Medical Device

27 March

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

Here

AICA

Supplement

28 March

Guidance for Industry and Food and Drug Administration Staff: Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi

Here

Here

Guidance

Medical Device

29 March

Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel

Here

Standards

Drugs

1 April

Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers

Here

Regulation

Medical Device

1 April

Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants

Here

Here

Guidance

Biologic

1 April

Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment Addendum

Here

Guidance

Drugs

2 April

Change of Address; Biologics License Applications; Technical Amendment

Here

Administrative

Biologic

2 April

Center for Devices and Radiological Health: Experiential Learning Program

Here

Here

Administrative

Medical Device

2 April

Guidance for Industry and Food and Drug Administration Staff: User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications

Here

Here

Guidance

General

2 April

Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish Pilot Projects and Submit a Report to Congress for the Improvement of Tracking and Tracing of Food; Extension of Comment Period

Here

Administrative

Supplement

2 April

International Consortium of Cardiovascular Registries

Here

Here

Meeting

Medical Device

2 April

Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule

Here

Meeting

Medical Device

2 April

Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use

Here

Here

Administrative

General

2 April

New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin

Here

Administrative

Veterinary

3 April

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request: Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

Here

AICA

Medical Device

3 April

Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4

Here

Here

Guidance

Medical Device

3 April

Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose

Here

Reclassification

Medical Device

4 April

 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference: Driving Quality and Compliance Throughout the Product Life Cycle in a Global Regulatory Environment

Here

Meeting

Drugs

4 April

Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food

Here

Administrative

Supplement

4 April

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee; Amendment of Notice

Here

Administrative

Drugs

4 April

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting

Here

Meeting

Medical Device

4 April

Peripheral and Central Nervous System Drugs Advisory Committee

Here

Meeting

Drugs

5 April

Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization

Here

AICA

Medical Device

5 April

Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval

Here

AICA

Medical Device

5 April

 Medical Countermeasures Initiative Regulatory Science Symposium

Here

Meeting

Medical Device

5 April

Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice

Here

Meeting

General

5 April

Vaccines and Related Biological Products Advisory Committee

Here

Meeting

Biologic

5 April

Pediatric Device Consortia Grant Program

Here

Administrative

Medical Device

5 April

Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices

Here

Meeting

Medical Device

8 April

Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Investigational New Drug Applications

Here

Here

Administrative

Biologic

8 April

Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

Here

Standards

Drugs

8 April

Draft Guidance for Industry on Providing Postmarket Periodic Safety Reports in the International Conference on Harmonisation E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)

Here

Here

Guidance

Drugs

8 April

Center for Devices and Radiological Health: Health of Women Program

Here

Here

Meeting

Medical Device

9 April

New Animal Drugs; Change of Sponsor

Here

Administrative

Veterinary

9 April

Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act

Here

Here

Administrative

Drugs

9 April

Draft Guidance for Industry and Food and Drug Administration Staff: Molecular Diagnostic Instruments With Combined Functions

Here

Here

Guidance

Medical Device

11 April

Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products

Here

Here

Guidance

Drugs

11 April

Guidance for Industry and Food and Drug Administration Staff: Medical Device Classification Product Codes

Here

Here

Guidance

Medical Device

11 April

Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years -2015

Here

Here

Administrative

Drugs

15 April

International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceutical To Limit Potential Carcinogenic Risk

Here

Here

Guidance

Drugs

15 April

Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

Here

Meeting

Drugs

16 April

Generic Drug Facilities, Sites, and Organizations

Here

Here

Administrative

Drugs

16 April

Document to Support Submission of an Electronic Common Technical Document-Specifications for File Format Types Using Electronic Common Technical Document Specifications

Here

Here

Administrative

Drugs

17 April

Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing Cross-Contamination

Here

Here

Guidance

Drugs

18 April

Determination That the OXYCONTIN (Oxycodone Hydrochloride) Drug Products Covered by New Drug Application 20-553 Were Withdrawn From Sale for Reasons of Safety or Effectiveness

Here

Here

Administrative

Drugs

18 April

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims

Here

AICA

Drugs

19 April

Use of Certain Symbols in Labeling

Here

Here

Regulation

Medical Device

19 April

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Clinical Laboratory Improvement Amendments Waiver Applications

Here

AICA

General

19 April

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Submission of Medical Device Registration and Listing

Here

AICA

Medical Device

19 April

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification

Here

AICA

Medical Device

19 April

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Health Care Professional Survey of Prescription Drug Promotion

Here

Here

AICA

Drugs

23 April

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational Device Exemptions Reports and Records

Here

AICA

Medical Device

23 April

Annual Public Meeting of Reagan-Udall Foundation

Here

Here

Meeting

General

23 April

Draft Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"

Here

Here

Guidance

Biologic

23 April

Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the Duration of the Program

Here

Here

Administrative

Medical Device

24 April

Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards

Here

AICA

General

23 April

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising

Here

Here

AICA

Drugs

24 April

Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors

Here

Here

Guidance

Drugs

25 April

Guidance for Industry and Food and Drug Administration Staff: Assay Migration Studies for In Vitro Diagnostic Devices

Here

Here

Guidance

Medical Device

25 April

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

Medical Device

26 April

Guidance for Industry on Regulatory Classification of Drugs Co-Crystals

Here

Here

Guidance

Drugs

30 April

New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin

Here

Administrative

Veterinary

30 April

Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications

Here

AICA

Veterinary

1 May

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance: Emergency Use Authorization of Medical Products

Here

AICA

General

1 May

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Inspection by Accredited Persons Program

Here

AICA

Medical Device

1 May

Ashley Brandon Foyle: Debarment Order

Here

Administrative

Drugs

2 May

Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

Here

AICA

Medical Device

2 May

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

Medical Device

2 May

Submission of New Drug Application/Abbreviated New Drug Application Field Alert Reports: Notice of Form FDA 3331-Automated Pilot Program

Here

Here

Administrative

Drugs

6 May

Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission Process for Voluntary Complaints to the Center for Devices and Radiological Health

Here

Here

AICA

Medical Device

6 May

An Evaluation of the Prescription Drug User Fee Act Workload Adjuster

Here

Administrative

Drugs

6 May

Food and Drug Administration/International Society for Drugs Engineering Co-Sponsorship Educational Workshop: Redefining the `C' in CGMP (Current Good Manufacturing Practices): Creating, Implementing, and Sustaining a Culture of Quality

Here

Meeting

Drugs

8 May

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request: Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Act

Here

AICA

Drugs

8 May

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation

Here

AICA

Biologic

8 May

David Freeman: Debarment Order

Here

Administrative

Drugs

8 May

Guidance for Industry: Implementation of an Acceptable Abbreviated Donor History Questionnaire and Accompanying Materials for Use in Screening Frequent Donors of Blood and Blood Components

Here

Here

Guidance

Blood Product

8 May

510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public Meeting

Here

Here

Meeting

Medical Device

8 May

Microbiology Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

Medical Device

9 May

General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products

Here

Here

Reclassification

Medical Device

9 May

Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers

Here

Here

Guidance

Drugs

9 May

Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use-Questions and Answers

Here

Here

Guidance

Drugs

9 May

Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing

Here

Here

Meeting

Drugs

10 May

Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

Here

AICA

Drugs

10 May

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

Here

AICA

Medical Device

10 May

Anesthetic and Analgesic Drug Products Advisory Committee

Here

Meeting

Drugs

13 May

New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor

Here

Administrative

Veterinary

13 May

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drug Applications and Supporting Regulations and Form FDA 356V

Here

AICA

Veterinary

13 May

Determination That REV-EYES (Dapiprazole Hydrochloride Ophthalmic Solution), 0.5%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Here

Administrative

Drugs

13 May

Dental Products Panel of the Medical Devices Advisory Committee

Here

Meeting

Medical Device

14 May

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Communicating Composite Scores in Direct-to-Consumer Advertising

Here

Here

AICA

General

14 May

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Product Labeling; Medication Guide Requirements

Here

AICA

Drugs

14 May

Guidance for Industry and Food and Drug Administration Staff on Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data

Here

Here

Guidance

Drugs

16 May

Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker

Here

Here

16 May

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to Center for Veterinary Medicine Using the Food and Drug Administration's Electronic Submission Gateway

Here

AICA

Veterinary

16 May

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Bar Code Label Requirement for Human Drug and Biological Products

Here

AICA

Drugs

16 May

Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance

Here

AICA

Medical Device

17 May

Guidance for Industry and FDA Staff: Center for Devices and Radiological Health Appeals Processes

Here

Here

Guidance

Medical Device

17 May

Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A; Draft Guidance for Industry and Food and Drug Administration Staff

Here

Here

Guidance

Medical Device

17 May

Anesthetic and Analgesic Drug Products Advisory Committee

Here

Meeting

Drugs

21 May

Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research

Here

Here

Meeting

Drugs

21 May

Cardiovascular Devices: Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina, etc.

Here

Reclassification

Medical Device

22 May

Standardizing and Evaluating Risk Evaluation and Mitigation Strategies

Here

Here

Meeting

Drugs

22 May

Oral Dosage Form New Animal Drugs: Clindamycin; Enrofloxacin

Here

Administrative

Veterinary

22 May

Meetings: Science Board to the Food and Drug Administration

Here

Meeting

General

22 May

Requests for Clinical Laboratory Improvement Amendments Categorization

Here

Administrative

General

23 May

Drug Safety and Risk Management Advisory Committee

Here

Meeting

Drugs

23 May

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

Medical Device

28 May

International Conference on Harmonisation Guidance; Availability: Q4B Evaluation and Recommendation of Pharmacopoeial Texts; Annex 13 on Bulk Density and Tapped Density of Powders

Here

Here

Guidance

Drugs

28 May

Draft Guidance for Industry; Availability: Contract Manufacturing Arrangements for Drugs; Quality Agreements

Here

Here

Guidance

Drugs

28 May

Clinical Development Programs for Opioid Conversion

Here

Meeting

Drugs

30 May

Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

Here

AICA

Drugs

30 May

Arthritis Advisory Committee

Here

Meeting

Drugs

30 May

Food and Drug Administration Safety and Innovation Act (FDASIA): Request for Comments on the Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology

Here

Here

Administrative

Medical Device

31 May

Draft Guidance for Industry; Availability: Rheumatoid Arthritis; Developing Drug Products for Treatment

Here

Here

Guidance

Drugs

31 May

Draft Guidance for Industry: Changes to an Approved Application; Biological Products, Human Blood and Blood Components Intended for Transfusion, etc.

Here

Here

Guidance

Biologic

31 May

New Approaches to Antibacterial Drug Development

Here

Here

Administrative

Drugs

4 June

New Drug Applications; Approval Withdrawals: ORAFLEX; Eli Lilly and Co.

Here

Drugs

4 June

Arthritis Advisory Committee

Here

Meeting

Biologic

4 June

Masked and De-identified Non-Summary Safety and Efficacy Data

Here

Here

Administrative

General

5 June

Lung Cancer Patient-Focused Drug Development

Here

Here

Meeting

Drugs

5 June

Battery-Powered Medical Devices Workshop: Challenges and Opportunities

Here

Here

Meeting

Medical Device

5 June

New Animal Drugs: Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction

Here

Administrative

Drugs

5 June

Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application

Here

Administrative

Drugs

5 June

Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A

Here

AICA

Biologic

5 June

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revision of the Requirements for Constituent Materials

Here

AICA

Drugs

5 June

Draft Guidance for Industry; Availabity: Human Immunodeficiency Virus-1 Infection; Developing Antiretroviral Drugs for Treatment

Here

Here

Guidance

Drugs

5 June

Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Forms FDA 3486 and 3486A

Here

AICA

Biologic

6 June

Script Your Future Medication Adherence Campaign

Here

Here

Administrative

Drugs

6 June

Drugs Not Withdrawn from Sale for Reasons of Safety or Effectiveness: SUBOXONE (Buprenorphine Hydrochloride and Naloxone Hydrochloride) Sublingual Tablets, 2 Milligrams/0.5 Milligrams and 8 Milligrams/2 Milligrams

Here

Administrative

Drugs

7 June

Guidance for Industry and Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

Here

Here

Guidance

Medical Device

11 June

Determination That CORDRAN (Flurandrenolide) Ointment USP, 0.025% and 0.05%, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Here

Drugs

12 June

Orphan Drug Regulations

Here

Here

Regulation

Drugs

12 June

Establishing List of Qualifying Pathogens under the Food and Drug Administration Safety and Innovation Act

Here

Here

Regulation

Drugs

12 June

Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Here

PMA Summary

Medical Device

12 June

Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Forms FDA 356h and 2567

Here

AICA

Biologic

12 June

Agency Information Collection Activities; Proposed Collection; Comment Request: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

Here

AICA

Drugs

12 June

Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products

Here

AICA

Medical Device

12 June

Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs

Here

Reclassification

Medical Device

12 June

Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)

Here

AICA

Drugs

14 June

Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff

Here

Here

Guidance

Medical Device

14 June

Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in Combination

Here

Here

Guidance

Drugs

14 June

Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff

Here

Here

Guidance

Medical Device

17 June

Agency Information Collection Activities: Proposed Collection; Comment Request; Applications for Food and Drug Administration Approval To Market a New Drug: Patent Submission and Listing Requirements

Here

AICA

Drugs

17 June

Draft Guidance for Industry and FDA Staff: Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System

Here

Here

Guidance

Biologic

17 June

Draft Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients With Disorders Affecting the Hematopoietic System; Availability

Here

Here

Guidance

Biologic

19 June

Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices; Notification of Public Meeting; Request for Comments

Here

Meeting

Drugs

19 June

Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study; Public Workshop

Here

Meeting

Drugs

19 June

Linking Marketplace Heparin Product Attributes and Manufacturing Processes to Bioactivity and Immunogenicity

Here

Here

Administrative

Biologic

19 June

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

Here

Meeting

Drugs

19 June

Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

Here

Reclassification

Medical Device

19 June

Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses

Here

Reclassification

Medical Device

20 June

Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations

Here

Guidance

Drugs

20 June

Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability

Here

Here

Guidance

Drugs

21 June

Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products

Here

AICA

Drugs

21 June

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Administrative Detention and Banned Medical Devices

Here

AICA

Medical Device

21 June

Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels

Here

Administrative

General

24 June

Nonprescription Drugs Advisory Committee; Notice of Meeting

Here

Here

Meeting

Drugs

24 June

Laser Products; Proposed Amendment to Performance Standard

Here

Here

Regulation

Medical Device

25 June

Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Here

Here

Administrative

Drugs

25 June

Regulatory Systems Strengthening

Here

Here

Administrative

General

25 June

Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality; Availability

Here

Here

Guidance

General

25 June

Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date

Here

Regulation

Medical Device

25 June

Authorization of Emergency Use of an In Vitro Diagnostic for Detection of the Novel Avian Influenza A(H7N9) Virus; Availability

Here

Administrative

Medical Device

26 June

Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologic

Here

Here

Guidance

Drugs

26 June

Blood Products Advisory Committee; Notice of Meeting

Here

Meeting

Biologic

27 June

Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting

Here

Meeting

Drugs

28 June

Agency Information Collection Activities: Proposed Collection; Comment Request; Focus Groups About Drug Products as Used by the Food and Drug Administration

Here

AICA

Drugs

28 June

Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products

Here

Here

AICA

Medical Device

28 June

Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff

Here

Here

Guidance

Medical Device

28 June

Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

Here

Here

Reclassification

Medical Device

1 July

Privacy Act, Exempt Record System; Implementation

Here

Here

Regulation

General

2 July

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements

Here

AICA

Medical Device

2 July

Draft Guidance for Industry on Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Availability

Here

Here

Guidance

Drugs

2 July

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling; Notification Procedures for Statements on Dietary Supplements

Here

AICA

Supplements

2 July

Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability

Here

Here

Guidance

Biologic

2 July

Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species

Here

AICA

Veterinary

2 July

Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs; Correction

Here

Regulation

Medical Device

5 July

Lung Cancer Patient-Focused Drug Development; Extension of Comment Period

Here

Administrative

Drugs

5 July

Determination That METADATE ER (Methylphenidate Hydrochloride) Extended-Release Tablet, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Here

Administrative

Drugs

9 July

Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff

Here

Here

Guidance

Medical Device

9 July

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval

Here

AICA

Medical Device

9 July

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information

Here

Here

AICA

General

9 July

Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products

Here

AICA

Medical Device

9 July

Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act

Here

AICA

Medical Device

10 July

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation

Here

AICA

Biologic

10 July

Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Animal Feed Regulatory Program Standards; Availability

Here

AICA

Veterinary

11 July

Establishment of a Public Docket for Comment on the Report Prepared Under the Food and Drug Administration Safety and Innovation Act Section 1138

Here

Here

Administrative

General

11 July

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Cancellation

Here

Meeting

Medical Device

12 July

Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Here

Meeting

Medical Device

12 July

Agency Information Collection Activities; Proposed Collection; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products: Establishment Registration and Listing; Form FDA 3356; Eligibility Determination for Donors; and Current Good Tissue Practice

Here

AICA

Biologic

15 July

Administrative Detention of Drugs Intended for Human or Animal Use

Here

Here

Regulation

Drugs

15 July

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Agreement for Shipment of Devices for Sterilization

Here

AICA

Medical Device

15 July

Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation

Here

Meeting

Drugs

15 July

Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability

Here

Here

Guidance

Drugs

15 July

Draft Guidance for Industry on Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans; Availability

Here

Here

Guidance

Drugs

15 July

Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug Evaluation and Research Data Standards Program Documents

Here

Administrative

Drugs

15 July

Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol

Here

Regulation

Drugs

15 July

Risk Communications Advisory Committee; Notice of Meeting

Here

Here

Meeting

Drugs

16 July

Listing of Color Additives Exempt from Certification: Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date

Here

Regulation

Medical Device

17 July

Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus

Here

Here

Administrative

Medical Device

18 July

Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation To Treat Clostridium difficile Infection Not Responsive to Standard Therapies

Here

Here

Guidance

Biologic

18 July

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs

Here

AICA

Drugs

18 July

Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Here

Here

Meeting

Drugs

19 July

Sensient Technologies Corporation; Withdrawal of Color Additive Petition

Here

Administrative

Drugs

19 July

Narcolepsy Public Meeting on Patient-Focused Drug Development

Here

Here

Meeting

Drugs

19 July

Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Application

Here

Administrative

Drugs

22 July

Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop

Here

Here

Meeting

Biologic

22 July

Compliance Policy Guide Sec. 253.100-Use of Units of Plasma and Fresh Frozen Plasma Which Have Been Thawed; Withdrawal of Compliance Policy Guide

Here

Administrative

Biologic

23 July

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting

Here

Meeting

Biologic

23 July

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards

Here

AICA

General

23 July

Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification

Here

AICA

Medical Device

23 July

Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices

Here

AICA

Medical Device

23 July

Food Advisory Committee; Notice of Meeting

Here

Here

Meeting

Dietary Supplement

23 July

Agency Information Collection Activities: Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling

Here

AICA

Drugs

24 July

Third Annual Food and Drug Administration Health Professional Organizations Conference

Here

Meeting

General

24 July

New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection

Here

 

Regulation

Veterinary

24 July

Guidance for Industry on Providing Submissions in Electronic Format-Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers

Here

Here

Guidance

Drugs

24 July

Draft Guidance for Industry on Pre-Launch Activities Importation Requests

Here

Here

Guidance

Drugs



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