Focus' Federal Register Tracking Tool for the Life Science Industry (Updated 25 July 2013)
Notice: This page is no longer being updated.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 | Drugs | |||
4 January | Advisory Committee for Reproductive Health Drugs | Meeting | Drugs | ||
4 January | Medical Imaging Drugs Advisory Committee | Meeting | Medical Device | ||
4 January | Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | PMA Update | Medical Device | ||
4 January | Accessible Medical Device Labeling in a Standard Content and Format | 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 | 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 | Reclassification | Medical Device | ||
7 January | Cardiovascular Devices; Reclassification of External Cardiac Compressor | Reclassification | Medical Device | ||
9 January | Privacy Act, Exempt Record System; Withdrawal | Regulation | General | ||
9 January | Privacy Act, Exempt Record System; Withdrawal | Regulation | General | ||
10 January | Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant | Reclassification | Medical Device | ||
10 January | Draft Guidance for Industry on Abuse-Deterrent Opioids-Evaluation and Labeling | Drugs | |||
10 January | Blood Products Advisory Committee | Meeting | Blood Product | ||
10 January | Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee | Meeting | Drugs | ||
13 January | Modifications to the List of Recognized Standards, Recognition List Number: 030 | Standards | Medical Device | ||
13 January | Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need | 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 | OMB Collection | General | ||
17 January | Generic Drug User Fee-Active Drugs Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year | Administrative | Drugs | ||
18 January | Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices | Reclassification | Medical Device | ||
18 January | Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements | OMB Collection | Supplement | ||
22 January | Current Good Manufacturing Practice Requirements for Combination Products | Regulation | Combination Product | ||
22 January | Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 | 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 | Combination Product | |||
22 January | Electronic Submission Process for Requesting Export Certificates From the Center for Devices and Radiological Health | Administrative | Medical Device | ||
24 January | Guidance for Industry and Food and Drug Administration Staff; Humanitarian Use Device (HUD) Designations | Medical Device | |||
24 January | Clinical Flow Cytometry in Hematologic Malignancies | Meeting | Medical Device | ||
25 January | Ophthalmic Devices; Classification of the Scleral Plug | 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 | OMB Collection | Drugs | ||
25 January | Vaccines and Related Biological Products Advisory Committee | Meeting | Biologic | ||
28 January | New Animal Drugs; Cefpodoxime; Meloxicam | Administrative | Veterinary | ||
28 January | Assuring Radiation Protection | Administrative | Medical Device | ||
28 January | Electronic Study Data Submission; Data Standard Support End Date | Administrative | Drugs | ||
28 January | Guidance for Industry on Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling | Drugs | |||
28 January | Detecting and Evaluating Drug-Induced Liver Injury; What's Normal, What's Not, and What Should We Do About It? | Meeting | Drugs | ||
29 January | Statement of Organization, Functions, and Delegations of Authority | Administrative | Veterinary | ||
30 January | Science Board to the Food and Drug Administration | 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 | 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 | AICA | Medical Device | ||
31 January | Determination That DIFFERIN (Adapalene) Solution, 0.1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Administrative | Drugs | ||
31 January | Considerations Regarding Food and Drug Administration Review and Regulation of Drugs for the Treatment of Amyotrophic Lateral Sclerosis | Meeting | General | ||
31 January | Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for Comments; Correction | Administrative | General | ||
31 January | Determination of Regulatory Review Period for Purposes of Patent Extension; BEYAZ | Administrative | Drugs | ||
31 January | Determination of Regulatory Review Period for Purposes of Patent Extension; XALKORI | Administrative | Drugs | ||
4 February | International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of Pharmaceutical | 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 | Drugs, Biologic | |||
6 February | Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement Initiative | Administrative | Drugs | ||
6 February | Training Program for Regulatory Project Managers | Administrative | Drugs | ||
6 February | Medical Device User Fee Cover Sheet, Form FDA 3601 | Administrative | Medical Device | ||
6 February | Administrative Detention and Banned Medical Devices | Administrative | Medical Device | ||
7 February | Dental Devices; Reclassification of Temporary Mandibular Condyle Prosthesis | Reclassification | Medical Device | ||
7 February | Request for Nominations for Voting Members on Public Advisory Panels or Committees | Meeting | Medical Device | ||
8 February | Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight | 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 | AICA | General | ||
8 February | Draft Guidance for Industry on Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease | Drugs | |||
8 February | International Drug Scheduling; Convention on Psychotropic Substances; World Health Organization Scheduling Recommendations for Gamma-hydroxybutyric Acid | Administrative | Drugs | ||
11 February | Draft Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products | Drugs, Biologic | |||
11 February | Food and Drug Administration/Xavier University PharmaLink Conference-Quality in a Global Supply Chain | Meeting | Drugs | ||
12 February | Food and Drug Administration Drug Shortages Task Force and Strategic Plan | 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 | AICA | Medical Device | ||
13 February | Documents To Support Submission of an Electronic Common Technical Document | Administrative | Drugs | ||
13 February | Annual Computational Science Symposium; Conference | Meeting | Drugs | ||
13 February | Global Quality Systems-An Integrated Approach To Improving Medical Product Safety | 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 | 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 | Medical Device | |||
15 February | Circulatory System Devices Panel of the Medical Devices Advisory Committee | Meeting | Medical Device | ||
15 February | Transmissible Spongiform Encephalopathies Advisory Committee | 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 | 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 | 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 | Medical Device | |||
19 February | Neonatal Subcommittee of the Pediatric Advisory Committee | Meeting | General | ||
20 February | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations | AICA | General | ||
21 February | Extreme Weather Effects on Medical Device Safety and Quality | Administrative | Medical Device | ||
21 February | Device Good Manufacturing Practice Advisory Committee | Meeting | Medical Device | ||
22 February | Draft Guidance for Industry and Food and Drug Administration Staff: Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements | Medical Device | |||
22 February | Determination of Regulatory Review Period for Purposes of Patent Extension; Sapien Transcatheter Heart Valve | 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 | Administrative | General | ||
25 February | Fecal Microbiota for Transplantation | Meeting | Biologic | ||
25 February | Pediatric Advisory Committee | Meeting | Drugs | ||
25 February | Joint Meeting of the Medical Imaging Drugs Advisory Committee and the Oncologic Drugs Advisory Committee | 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 | Supplement | |||
25 February | Guidance for Industry on Labeling for Human Prescription Drug and Biological Products-Implementing the Physician Labeling Rule Content and Format Requirements | 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 | Drugs | |||
25 February | Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices | Regulation | Medical Device | ||
26 February | Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products | Regulation | General | ||
26 February | Agency Information Collection Activities: Proposed Collection; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | 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 | Blood Product | |||
26 February | Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial Disclosure by Clinical Investigators | 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 | Blood Product | |||
26 February | Seventh Annual Drug Information Association/Food and Drug Administration Statistics Forum- | Meeting | General | ||
27 February | Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee | Meeting | Medical Device | ||
27 February | Oncologic Drugs Advisory Committee | Meeting | Drugs | ||
27 February | Ophthalmic Devices Panel of the Medical Devices Advisory Committee | Meeting | Medical Device | ||
27 February | Psychopharmacologic Drugs Advisory Committee | Meeting | Drugs | ||
27 February | Science Board to the Food and Drug Administration Advisory Committee; Amendment of Notice | Meeting | General | ||
28 February | Draft Guidance for Industry and Review Staff on Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling | Drugs | |||
28 February | Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements | AICA | Medical Device | ||
28 February | Determination of Regulatory Review Period for Purposes of Patent Extension; LAVIV | Administrative | Biologic | ||
28 February | Determination of Regulatory Review Period for Purposes of Patent Extension; ZYTIGA | Administrative | Drugs | ||
4 March | Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff | Medical Device | |||
4 March | Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport | Regulation | Medical Device | ||
4 March | Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator | 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 | 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 | 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)) | 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)) | 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; | Administrative | Supplement | ||
6 March | Cheng Yi Liang: Debarment Order | Administrative | General | ||
6 March | Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses | Medical Device | |||
7 March | New Animal Drug Applications; Alfaprostol; Bicyclohexylammonium Fumagillin; N | Administrative | Veterinary | ||
7 March | Veterinary Oversight of Antimicrobial Use in Livestock: Impact on Stakeholders | Meeting | Veterinary | ||
7 March | Ag-Mark, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications | Administrative | Veterinary | ||
8 March | Guidance for Industry: What You Need To Know About Administrative Detention of Foods; Small Entity Compliance Guide | Supplement | |||
8 March | Food and Drug Administration Prescription Drug User Fee Act V Benefit-Risk Plan | 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 | Medical Device | |||
11 March | Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis | Meeting | Drugs | ||
12 March | Cellular, Tissue and Gene Therapies Advisory Committee | 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 | 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 | Administrative | Drugs | ||
13 March | Draft Guidance for Industry and Review Staff on Formal Dispute Resolution: Appeals Above the Division Level | Drugs | |||
13 March | Guidance for Industry on Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation | Drugs | |||
13 March | Food and Drug Administration/Xavier University Global Medical Device Conference | Meeting | Medical Device | ||
14 March | Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee | Meeting | Biologic | ||
15 March | Institutional Review Boards; Correcting Amendments | 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 | 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 | AICA | Medical Device | ||
18 March | Center for Drug Evaluation and Research Medical Policy Council | Administrative | General | ||
18 March | International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of Pharmaceutical | Administrative | Drugs | ||
18 March | General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee | Meeting | Medical Device | ||
18 March | Impax Laboratories, Inc.; Withdrawal of Approval of Bupropion Hydrochloride Extended-Release Tablets, 300 Milligrams | Administrative | Drugs | ||
20 March | Public Hearing Before a Public Advisory Committee; Technical Amendments | Regulation | General | ||
20 March | Agency Information Collection Activities: Proposed Collection; Comment Request; Current Good Manufacturing Practice for Positron Emission Tomography Drugs | AICA | Drugs | ||
21 March | Pulmonary-Allergy Drugs Advisory Committee | Meeting | Drugs | ||
21 March | Risk Communications Advisory Committee | Meeting | General | ||
21 March | Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | PMA Update | Medical Device | ||
22 March | New Animal Drugs; Changes of Sponsor | Administrative | Veterinary | ||
22 March | Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases | 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 | Administrative | Veterinary | ||
25 March | Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System | 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 | Administrative | Drugs | ||
25 March | Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Extension of Comment Period | Meeting | Medical Device | ||
26 March | Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United States; Agent Designation; Change of Address | Administrative | Medical Device | ||
26 March | Medical Devices; Technical Amendment | Administrative | Medical Device | ||
26 March | Food Labeling; Notification Procedures for Statements on Dietary Supplements | 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 | Administrative | Drugs | ||
26 March | Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability | Blood Product | |||
27 March | Summit on Color in Medical Imaging; Cosponsored Public Workshop; Request for Comments | 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 | 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 | Medical Device | |||
29 March | Draft Guidance for Industry on Bioequivalence Recommendations for Metronidazole Vaginal Gel | Standards | Drugs | ||
1 April | Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers | Regulation | Medical Device | ||
1 April | Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product Sponsors or Applicants | Biologic | |||
1 April | Draft Guidance for Industry on Scale-Up and Post-Approval Changes: Manufacturing Equipment Addendum | Drugs | |||
2 April | Change of Address; Biologics License Applications; Technical Amendment | Administrative | Biologic | ||
2 April | Center for Devices and Radiological Health: Experiential Learning Program | 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 | 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 | Administrative | Supplement | ||
2 April | International Consortium of Cardiovascular Registries | Meeting | Medical Device | ||
2 April | Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule | Meeting | Medical Device | ||
2 April | Modifications To Labeling of Nicotine Replacement Therapy Products for Over-the-Counter Human Use | Administrative | General | ||
2 April | New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin | 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 | 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 | 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 | 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 | Meeting | Drugs | ||
4 April | Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration-Human and Animal Food | 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 | Administrative | Drugs | ||
4 April | Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting | Meeting | Medical Device | ||
4 April | Peripheral and Central Nervous System Drugs Advisory Committee | Meeting | Drugs | ||
5 April | Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization | AICA | Medical Device | ||
5 April | Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval | AICA | Medical Device | ||
5 April | Medical Countermeasures Initiative Regulatory Science Symposium | 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 | Meeting | General | ||
5 April | Vaccines and Related Biological Products Advisory Committee | Meeting | Biologic | ||
5 April | Pediatric Device Consortia Grant Program | Administrative | Medical Device | ||
5 April | Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices | Meeting | Medical Device | ||
8 April | Center for Biologics Evaluation and Research eSubmitter Pilot Evaluation Program for Investigational New Drug Applications | Administrative | Biologic | ||
8 April | Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations | 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) | Drugs | |||
8 April | Center for Devices and Radiological Health: Health of Women Program | Meeting | Medical Device | ||
9 April | New Animal Drugs; Change of Sponsor | Administrative | Veterinary | ||
9 April | Establishment of a Public Docket for Administrative Detention Under the Food and Drug Administration Safety and Innovation Act | Administrative | Drugs | ||
9 April | Draft Guidance for Industry and Food and Drug Administration Staff: Molecular Diagnostic Instruments With Combined Functions | Medical Device | |||
11 April | Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products | Drugs | |||
11 April | Guidance for Industry and Food and Drug Administration Staff: Medical Device Classification Product Codes | Medical Device | |||
11 April | Prescription Drug User Fee Act Patient-Focused Drug Development; Announcement of Disease Areas for Meetings Conducted in Fiscal Years -2015 | 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 | Drugs | |||
15 April | Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee | Meeting | Drugs | ||
16 April | Generic Drug Facilities, Sites, and Organizations | 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 | Administrative | Drugs | ||
17 April | Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices Framework for Preventing Cross-Contamination | 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 | Administrative | Drugs | ||
18 April | Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims | AICA | Drugs | ||
19 April | Use of Certain Symbols in Labeling | 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 | AICA | General | ||
19 April | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Electronic Submission of Medical Device Registration and Listing | 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 | 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 | AICA | Drugs | ||
23 April | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational Device Exemptions Reports and Records | AICA | Medical Device | ||
23 April | Annual Public Meeting of Reagan-Udall Foundation | 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" | Biologic | |||
23 April | Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the Duration of the Program | Administrative | Medical Device | ||
24 April | Agency Information Collection Activities; Proposed Collection; Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards | 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 | AICA | Drugs | ||
24 April | Draft Guidance for Industry on Safety Considerations for Container Labels and Carton Labeling Design To Minimize Medication Errors | Drugs | |||
25 April | Guidance for Industry and Food and Drug Administration Staff: Assay Migration Studies for In Vitro Diagnostic Devices | Medical Device | |||
25 April | Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee | Meeting | Medical Device | ||
26 April | Guidance for Industry on Regulatory Classification of Drugs Co-Crystals | Drugs | |||
30 April | New Animal Drugs; Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin | Administrative | Veterinary | ||
30 April | Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications | AICA | Veterinary | ||
1 May | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance: Emergency Use Authorization of Medical Products | AICA | General | ||
1 May | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices; Inspection by Accredited Persons Program | AICA | Medical Device | ||
1 May | Ashley Brandon Foyle: Debarment Order | Administrative | Drugs | ||
2 May | Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications | AICA | Medical Device | ||
2 May | Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee | 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 | 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 | AICA | Medical Device | ||
6 May | An Evaluation of the Prescription Drug User Fee Act Workload Adjuster | 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 | 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 | 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 | AICA | Biologic | ||
8 May | David Freeman: Debarment Order | 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 | Blood Product | |||
8 May | 510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device; Public Meeting | Meeting | Medical Device | ||
8 May | Microbiology Devices Panel of the Medical Devices Advisory Committee | Meeting | Medical Device | ||
9 May | General and Plastic Surgery Devices: Reclassification of Ultraviolet Lamps for Tanning, Henceforth To Be Known as Sunlamp Products | Reclassification | Medical Device | ||
9 May | Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers | Drugs | |||
9 May | Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use-Questions and Answers | Drugs | |||
9 May | Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Public Hearing | 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 | 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 | AICA | Medical Device | ||
10 May | Anesthetic and Analgesic Drug Products Advisory Committee | Meeting | Drugs | ||
13 May | New Animal Drugs; Change of Sponsor's Name and Address; Change of Sponsor | 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 | 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 | Administrative | Drugs | ||
13 May | Dental Products Panel of the Medical Devices Advisory Committee | 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 | AICA | General | ||
14 May | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Prescription Drug Product Labeling; Medication Guide Requirements | 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 | Drugs | |||
16 May | Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the Ingestible Event Marker | ||||
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 | 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 | AICA | Drugs | ||
16 May | Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance | AICA | Medical Device | ||
17 May | Guidance for Industry and FDA Staff: Center for Devices and Radiological Health Appeals Processes | 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 | Medical Device | |||
17 May | Anesthetic and Analgesic Drug Products Advisory Committee | Meeting | Drugs | ||
21 May | Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research | Meeting | Drugs | ||
21 May | Cardiovascular Devices: Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina, etc. | Reclassification | Medical Device | ||
22 May | Standardizing and Evaluating Risk Evaluation and Mitigation Strategies | Meeting | Drugs | ||
22 May | Oral Dosage Form New Animal Drugs: Clindamycin; Enrofloxacin | Administrative | Veterinary | ||
22 May | Meetings: Science Board to the Food and Drug Administration | Meeting | General | ||
22 May | Requests for Clinical Laboratory Improvement Amendments Categorization | Administrative | General | ||
23 May | Drug Safety and Risk Management Advisory Committee | Meeting | Drugs | ||
23 May | General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee | 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 | Drugs | |||
28 May | Draft Guidance for Industry; Availability: Contract Manufacturing Arrangements for Drugs; Quality Agreements | Drugs | |||
28 May | Clinical Development Programs for Opioid Conversion | 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 | AICA | Drugs | ||
30 May | Arthritis Advisory Committee | 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 | Administrative | Medical Device | ||
31 May | Draft Guidance for Industry; Availability: Rheumatoid Arthritis; Developing Drug Products for Treatment | Drugs | |||
31 May | Draft Guidance for Industry: Changes to an Approved Application; Biological Products, Human Blood and Blood Components Intended for Transfusion, etc. | Biologic | |||
31 May | New Approaches to Antibacterial Drug Development | Administrative | Drugs | ||
4 June | New Drug Applications; Approval Withdrawals: ORAFLEX; Eli Lilly and Co. | Drugs | |||
4 June | Arthritis Advisory Committee | Meeting | Biologic | ||
4 June | Masked and De-identified Non-Summary Safety and Efficacy Data | Administrative | General | ||
5 June | Lung Cancer Patient-Focused Drug Development | Meeting | Drugs | ||
5 June | Battery-Powered Medical Devices Workshop: Challenges and Opportunities | Meeting | Medical Device | ||
5 June | New Animal Drugs: Dexmedetomidine; Lasalocid; Melengestrol; Monensin; and Tylosin; Correction | Administrative | Drugs | ||
5 June | Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application | 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 | 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 | AICA | Drugs | ||
5 June | Draft Guidance for Industry; Availabity: Human Immunodeficiency Virus-1 Infection; Developing Antiretroviral Drugs for Treatment | 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 | AICA | Biologic | ||
6 June | Script Your Future Medication Adherence Campaign | 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 | 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 | 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 | Drugs | |||
12 June | Orphan Drug Regulations | Regulation | Drugs | ||
12 June | Establishing List of Qualifying Pathogens under the Food and Drug Administration Safety and Innovation Act | Regulation | Drugs | ||
12 June | Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | 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 | 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 | AICA | Drugs | ||
12 June | Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Products | AICA | Medical Device | ||
12 June | Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs | 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) | 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 | Guidance | Medical Device | ||
14 June | Guidance for Industry on Codevelopment of Two or More New Investigational Drugs for Use in Combination | Drugs | |||
14 June | Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff | 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 | 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 | 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 | 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 | Meeting | Drugs | ||
19 June | Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study; Public Workshop | Meeting | Drugs | ||
19 June | Linking Marketplace Heparin Product Attributes and Manufacturing Processes to Bioactivity and Immunogenicity | Administrative | Biologic | ||
19 June | Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting | Meeting | Drugs | ||
19 June | Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis | 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 | Reclassification | Medical Device | ||
20 June | Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations | Guidance | Drugs | ||
20 June | Guidance for Industry; Guidance on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products; Availability | 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 | AICA | Drugs | ||
21 June | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Administrative Detention and Banned Medical Devices | 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 | Administrative | General | ||
24 June | Nonprescription Drugs Advisory Committee; Notice of Meeting | Meeting | Drugs | ||
24 June | Laser Products; Proposed Amendment to Performance Standard | 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 | Administrative | Drugs | ||
25 June | Regulatory Systems Strengthening | Administrative | General | ||
25 June | Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality; Availability | General | |||
25 June | Listing of Color Additives Exempt From Certification; Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date | 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 | Administrative | Medical Device | ||
26 June | Draft Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologic | Drugs | |||
26 June | Blood Products Advisory Committee; Notice of Meeting | Meeting | Biologic | ||
27 June | Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting | 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 | AICA | Drugs | ||
28 June | Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products | AICA | Medical Device | ||
28 June | Implanted Blood Access Devices for Hemodialysis; Draft Guidance for Industry and Food and Drug Administration Staff | Medical Device | |||
28 June | Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices | Medical Device | |||
1 July | Privacy Act, Exempt Record System; Implementation | Regulation | General | ||
2 July | Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements | 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 | Drugs | |||
2 July | Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling; Notification Procedures for Statements on Dietary Supplements | AICA | Supplements | ||
2 July | Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability | Biologic | |||
2 July | Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species | AICA | Veterinary | ||
2 July | Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs; Correction | Regulation | Medical Device | ||
5 July | Lung Cancer Patient-Focused Drug Development; Extension of Comment Period | 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 | Administrative | Drugs | ||
9 July | Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff | 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 | 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 | AICA | General | ||
9 July | Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products | 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 | AICA | Medical Device | ||
10 July | Agency Information Collection Activities; Proposed Collection; Comment Request; Human Tissue Intended for Transplantation | AICA | Biologic | ||
10 July | Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Animal Feed Regulatory Program Standards; Availability | 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 | Administrative | General | ||
11 July | Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Cancellation | 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 | 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 | AICA | Biologic | ||
15 July | Administrative Detention of Drugs Intended for Human or Animal Use | 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 | AICA | Medical Device | ||
15 July | Anesthetic and Analgesic Drug Products Advisory Committee; Cancellation | Meeting | Drugs | ||
15 July | Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability | 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 | Drugs | |||
15 July | Electronic Study Data Submission; Data Standard Support; Availability of the Center for Drug Evaluation and Research Data Standards Program Documents | Administrative | Drugs | ||
15 July | Oral Dosage Form New Animal Drugs; Nicarbazin; Oclacitinib; Zilpaterol | Regulation | Drugs | ||
15 July | Risk Communications Advisory Committee; Notice of Meeting | Meeting | Drugs | ||
16 July | Listing of Color Additives Exempt from Certification: Reactive Blue 246 and Reactive Blue 247 Copolymers; Confirmation of Effective Date | Regulation | Medical Device | ||
17 July | Authorization of Emergency Use of an In Vitro Diagnostic for Detection of Middle East Respiratory Syndrome Coronavirus | 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 | 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 | AICA | Drugs | ||
18 July | Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting | Meeting | Drugs | ||
19 July | Sensient Technologies Corporation; Withdrawal of Color Additive Petition | Administrative | Drugs | ||
19 July | Narcolepsy Public Meeting on Patient-Focused Drug Development | Meeting | Drugs | ||
19 July | Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Application | Administrative | Drugs | ||
22 July | Synergizing Efforts in Standards Development for Cellular Therapies and Regenerative Medicine Products; Public Workshop | 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 | Administrative | Biologic | ||
23 July | Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting | 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 | AICA | General | ||
23 July | Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification | AICA | Medical Device | ||
23 July | Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Approval of Medical Devices | AICA | Medical Device | ||
23 July | Food Advisory Committee; Notice of Meeting | Meeting | Dietary Supplement | ||
23 July | Agency Information Collection Activities: Proposed Collection; Comment Request; Format and Content Requirements for Over-the-Counter Drug Product Labeling | AICA | Drugs | ||
24 July | Third Annual Food and Drug Administration Health Professional Organizations Conference | Meeting | General | ||
24 July | New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection | | Regulation | Veterinary | |
24 July | Guidance for Industry on Providing Submissions in Electronic Format-Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers | Drugs | |||
24 July | Draft Guidance for Industry on Pre-Launch Activities Importation Requests | Drugs |