Regulatory Focus™ > News Articles > Federal Register Tracking Database

Federal Register Tracking Database

Posted 03 June 2013 | By Alexander Gaffney, RAC

Date

Title

In Focus

Federal Register

FDA Link

3 January 2013

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

Here

Here

Guidance

4 January 2013

Advisory Committee for Reproductive Health Drugs

Here

Meeting

4 January 2013

Medical Imaging Drugs Advisory Committee

Here

Meeting

4 January 2013

Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

Here

4 January 2013

Accessible Medical Device Labeling in a Standard Content and Format

Here

Here

Meeting

4 January 2013

Guidance on Medical Devices: The Pre-Submission Program and Meetings With FDA Staff; Withdrawal

Here

Here

7 January 2013

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

7 January 2013

Cardiovascular Devices; Reclassification of External Cardiac Compressor

Here

Here

9 January 2013

Privacy Act, Exempt Record System; Withdrawal

Here

Here

9 January 2013

Privacy Act, Exempt Record System; Withdrawal

Here

Here

10 January 2013

Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant

Here

Here

10 January 2013

Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling

Here

Here

Guidance

10 January 2013

Blood Products Advisory Committee

Here

Here

Meeting

10 January 2013

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

Here

Meeting

13 January 2013

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

Here

Here

13 January 2013

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

Here

Here

Meeting

16 January 2013

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

17 January 2013

Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year 2013

Here

Here

18 January 2013

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

Here

Here

18 January 2013

Notification Procedures for Statements on Dietary Supplements

Here

22 January 2013

Current Good Manufacturing Practice Requirements for Combination Products

Here

Here

22 January 2013

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

Here

22 January 2013

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

22 January 2013

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

Here

Here

24 January 2013

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

Here

Here

Guidance

24 January 2013

Clinical Flow Cytometry in Hematologic Malignancies

Here

Meeting

25 January 2013

Ophthalmic Devices; Classification of the Scleral Plug

Here

25 January 2013

Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008

Here

Here

25 January 2013

Vaccines and Related Biological Products Advisory Committee

Here

Meeting

28 January 2013

New Animal Drugs; Cefpodoxime; Meloxicam

Here

28 January 2013

2013 Assuring Radiation Protection

Here

Here

28 January 2013

Electronic Study Data Submission; Data Standard Support End Date

Here

Here

28 January 2013

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

Here

Here

Guidance

28 January 2013

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

Here

Here

Meeting

29 January 2013

Statement of Organization, Functions, and Delegations of Authority

Here

30 January 2013

Science Board to the Food and Drug Administration

Here

Here

Meeting

31 January 2013

Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification

Here

31 January 2013

Medical Devices; Inspection by Accredited Persons Program

Here

31 January 2013

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

Here

31 January 2013

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

Here

Here

Meeting

31 January 2013

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

Here

31 January 2013

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

Here

31 January 2013

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

Here

4 February 2013

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

Here

Here

Guidance

4 February 2013

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

6 February 2013

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

Here

Here

6 February 2013

Training Program for Regulatory Project Managers

Here

Here

6 February 2013

Medical Device User Fee Cover Sheet, Form FDA 3601

Here

6 February 2013

Administrative Detention and Banned Medical Devices

Here

7 February 2013

Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis

Here

7 February 2013

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

Here

Here

Meeting

8 February 2013

Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight

Here

8 February 2013

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

Here

8 February 2013

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

Here

Here

Guidance

8 February 2013

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

Here

Here

11 February 2013

Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products

Here

Here

Guidance

11 February 2013

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

Here

Meeting

12 February 2013

Food and Drug Administration Drug Shortages Task Force and Strategic Plan

Here

Here

13 February 2013

Guidance for Industry and Food and Drug Administration Staff; Center for Devices and Radiological Health Appeals Processes

Here

13 February 2013

Documents To Support Submission of an Electronic Common Technical Document

Here

Here

13 February 2013

Annual Computational Science Symposium; Conference

Here

Meeting

13 February 2013

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

Here

Meeting

15 February 2013

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

15 February 2013

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

Here

Here

Guidance

15 February 2013

Circulatory System Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

15 February 2013

Transmissible Spongiform Encephalopathies Advisory Committee

Here

Meeting

19 February 2013

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

19 February 2013

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

19 February 2013

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

19 February 2013

Neonatal Subcommittee of the Pediatric Advisory Committee

Here

Meeting

20 February 2013

Environmental Impact Considerations

Here

21 February 2013

Extreme Weather Effects on Medical Device Safety and Quality

Here

Here

21 February 2013

Device Good Manufacturing Practice Advisory Committee

Here

Here

Meeting

22 February 2013

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

Here

Here

Guidance

22 February 2013

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

Here

22 February 2013

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

25 February 2013

Fecal Microbiota for Transplantation

Here

Here

Meeting

25 February 2013

Pediatric Advisory Committee

Here

Meeting

25 February 2013

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

Here

Meeting

25 February 2013

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

25 February 2013

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

Here

Here

Guidance

25 February 2013

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

25 February 2013

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

Here

Here

26 February 2013

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

Here

26 February 2013

Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application

Here

26 February 2013

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

26 February 2013

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

Here

Here

Guidance

26 February 2013

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

26 February 2013

Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum-2013

Here

Meeting

27 February 2013

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

Here

Meeting

27 February 2013

Oncologic Drugs Advisory Committee

Here

Meeting

27 February 2013

Ophthalmic Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

27 February 2013

Psychopharmacologic Drugs Advisory Committee

Here

Meeting

27 February 2013

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

Here

Meeting

28 February 2013

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

Here

Here

Guidance

28 February 2013

Mammography Quality Standards Act Requirements

Here

28 February 2013

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

Here

28 February 2013

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

Here

4 March 2013

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

Here

Here

Guidance

4 March 2013

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

Here

4 March 2013

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

Here

4 March 2013

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

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

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

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

6 March 2013

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

6 March 2013

Cheng Yi Liang: Debarment Order

Here

Here

6 March 2013

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

Here

Here

Guidance

7 March 2013

New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N

Here

7 March 2013

Veterinary Oversight of Antimicrobial Use in Livestock: Impact on Stakeholders

Here

Meeting

7 March 2013

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

Here

8 March 2013

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

Here

Guidance

8 March 2013

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

Here

11 March 2013

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

11 March 2013

Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis

Here

Here

Meeting

12 March 2013

Cellular, Tissue and Gene Therapies Advisory Committee

Here

Meeting

13 March 2013

Guidance on Reagents for Detection of Specific Novel Influenza A Viruses

Here

13 March 2013

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

Here

Here

13 March 2013

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

Here

Here

Guidance

13 March 2013

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

Here

Here

Guidance

13 March 2013

Food and Drug Administration/Xavier University Global Medical Device Conference

Here

Meeting

14 March 2013

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

Here

Meeting

15 March 2013

Institutional Review Boards; Correcting Amendments

Here

15 March 2013

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

18 March 2013

Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k)] Submissions

Here

18 March 2013

Center for Drug Evaluation and Research Medical Policy Council

Here

Here

18 March 2013

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

Here

18 March 2013

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

Here

Meeting

18 March 2013

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

Here

Here

20 March 2013

Public Hearing Before a Public Advisory Committee; Technical Amendments

Here

20 March 2013

Current Good Manufacturing Practice for Positron Emission Tomography Drugs

Here

21 March 2013

Pulmonary-Allergy Drugs Advisory Committee

Here

Meeting

21 March 2013

Risk Communications Advisory Committee

Here

Here

Meeting

21 March 2013

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

Here

22 March 2013

New Animal Drugs; Changes of Sponsor

Here

22 March 2013

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

Here

Here

25 March 2013

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

Here

25 March 2013

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

Here

Here

25 March 2013

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

Here

25 March 2013

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

Here

Meeting

26 March 2013

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

Here

26 March 2013

Medical Devices; Technical Amendment

Here

26 March 2013

Food Labeling; Notification Procedures for Statements on Dietary Supplements

Here

26 March 2013

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

26 March 2013

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

Here

Here

Guidance

27 March 2013

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

Here

Here

Meeting

27 March 2013

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

Here

28 March 2013

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

29 March 2013

Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel

Here

1 April 2013

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

Here

1 April 2013

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

Here

Here

Guidance

1 April 2013

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

Here

Guidance

2 April 2013

Change of Address; Biologics License Applications; Technical Amendment

Here

2 April 2013

Center for Devices and Radiological Health: Experiential Learning Program

Here

Here

2 April 2013

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

2 April 2013

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

2 April 2013

International Consortium of Cardiovascular Registries

Here

Here

Meeting

2 April 2013

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

Here

Meeting

2 April 2013

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

Here

Here

2 April 2013

New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin

Here

3 April 2013

Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements

Here

3 April 2013

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

3 April 2013

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

4 April 2013

2013 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

4 April 2013

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

Here

4 April 2013

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

Here

Meeting

4 April 2013

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

Here

Meeting

4 April 2013

Peripheral and Central Nervous System Drugs Advisory Committee

Here

Meeting

5 April 2013

Agreement for Shipment of Devices for Sterilization

Here

5 April 2013

Export of Medical Devices; Foreign Letters of Approval

Here

5 April 2013

2013 Medical Countermeasures Initiative Regulatory Science Symposium

Here

Meeting

5 April 2013

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

Here

Meeting

5 April 2013

Vaccines and Related Biological Products Advisory Committee

Here

Meeting

5 April 2013

Pediatric Device Consortia Grant Program

Here

5 April 2013

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

Here

Meeting

8 April 2013

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

Here

Here

8 April 2013

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

Here

8 April 2013

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

8 April 2013

Center for Devices and Radiological Health: Health of Women Program

Here

Here

Meeting

9 April 2013

New Animal Drugs; Change of Sponsor

Here

9 April 2013

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

Here

Here

9 April 2013

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

Here

Here

Guidance

11 April 2013

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

Here

Here

Guidance

11 April 2013

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

Here

Here

Guidance

11 April 2013

Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years 2013-2015

Here

Here

15 April 2013

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

Here

Here

Guidance

15 April 2013

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

Here

Meeting

16 April 2013

Generic Drug Facilities, Sites, and Organizations

Here

Here

16 April 2013

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

Here

Here

17 April 2013

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

Here

Here

Guidance

18 April 2013

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

18 April 2013

Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims

Here

19 April 2013

Use of Certain Symbols in Labeling

Here

Here

19 April 2013

Clinical Laboratory Improvement Amendments Waiver Applications

Here

19 April 2013

Electronic Submission of Medical Device Registration and Listing

Here

19 April 2013

Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical Device User Fee Small Business Qualification and Certification

Here

19 April 2013

Health Care Professional Survey of Prescription Drug Promotion

Here

Here

23 April 2013

Investigational Device Exemptions Reports and Records

Here

23 April 2013

Annual Public Meeting of Reagan-Udall Foundation

Here

Here

Meeting

23 April 2013

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

23 April 2013

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

Here

Here

24 April 2013

Protection of Human Subjects: Informed Consent; Institutional Review Boards

Here

23 April 2013

Experimental Study: Examination of Corrective Direct-to-Consumer Television Advertising

Here

Here

24 April 2013

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

Here

Here

Guidance

25 April 2013

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

Here

Here

Guidance

25 April 2013

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

26 April 2013

Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals

Here

Here

Guidance

30 April 2013

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

Here

30 April 2013

Abbreviated New Animal Drug Applications

Here

1 May 2013

Guidance: Emergency Use Authorization of Medical Products

Here

1 May 2013

Medical Devices; Inspection by Accredited Persons Program

Here

1 May 2013

Ashley Brandon Foyle: Debarment Order

Here

2 May 2013

Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications

Here

2 May 2013

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

2 May 2013

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

Here

Here

6 May 2013

Electronic Submission Process for Voluntary Complaints to the Center for Devices and Radiological Health

Here

Here

6 May 2013

An Evaluation of the Prescription Drug User Fee Act Workload Adjuster

Here

6 May 2013

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

Here

Meeting

8 May 2013

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

8 May 2013

Public Health Service Guideline on Infectious Disease Issues on Xenotransplantation

Here

8 May 2013

David Freeman: Debarment Order

Here

8 May 2013

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

8 May 2013

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

Here

Here

Meeting

8 May 2013

Microbiology Devices Panel of the Medical Devices Advisory Committee

Here

Meeting

9 May 2013

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

Here

Here

9 May 2013

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

Here

Here

Guidance

9 May 2013

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

Here

Here

Guidance

9 May 2013

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

Here

Here

Meeting

10 May 2013

Applications for Food and Drug Administration Approval To Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

Here

10 May 2013

Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

Here

10 May 2013

Anesthetic and Analgesic Drug Products Advisory Committee

Here

13 May 2013

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

Here

13 May 2013

New Animal Drug Applications and Supporting Regulations and Form FDA 356V

Here

13 May 2013

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

Here

13 May 2013

Dental Products Panel of the Medical Devices Advisory Committee

Here

Meeting

14 May 2013

Communicating Composite Scores in Direct-to-Consumer Advertising

Here

Here

14 May 2013

Prescription Drug Product Labeling; Medication Guide Requirements

Here

14 May 2013

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

16 May 2013

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

Here

Here

16 May 2013

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

16 May 2013

Bar Code Label Requirement for Human Drug and Biological Products

Here

16 May 2013

Postmarket Surveillance

Here

17 May 2013

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

Here

Here

Guidance

17 May 2013

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

17 May 2013

Anesthetic and Analgesic Drug Products Advisory Committee

Here

Meeting

21 May 2013

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

Here

Here

Meeting

21 May 2013

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

Here

22 May 2013

Standardizing and Evaluating Risk Evaluation and Mitigation Strategies

Here

Here

Meeting

22 May 2013

Oral Dosage Form New Animal Drugs: Clindamycin; Enrofloxacin

Here

22 May 2013

Meetings: Science Board to the Food and Drug Administration

Here

Meeting

22 May 2013

Requests for Clinical Laboratory Improvement Amendments Categorization

Here

23 May 2013

Drug Safety and Risk Management Advisory Committee

Here

Meeting

23 May 2013

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

Here

Meeting

28 May 2013

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

28 May 2013

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

Here

Here

Guidance

28 May 2013

Clinical Development Programs for Opioid Conversion

Here

Meeting

30 May 2013

Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format

Here

30 May 2013

Arthritis Advisory Committee

Here

Meeting

30 May 2013

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

31 May 2013

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

Here

Here

Guidance

31 May 2013

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

Here

Here

Here

31 May 2013

New Approaches to Antibacterial Drug Development

Here

Here

4 June 2013

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

Here

4 June 2013

Arthritis Advisory Committee

Here

Meeting

4 June 2013

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

Here

Here


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