Agency Archive

Food and Drug Administration

Recent Federal Register documents and issues associated with this agency.

Recent Documents

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address Thursday, April 16, 2026 91 FR 20337
Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, April 16, 2026 91 FR 20471
Determination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, April 16, 2026 91 FR 20464
Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs Thursday, April 16, 2026 91 FR 20460
Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT Thursday, April 16, 2026 91 FR 20467
Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs Thursday, April 16, 2026 91 FR 20462
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing for Medicated Premixes (Revision 1); Draft Guidance for Industry; Availability Thursday, April 16, 2026 91 FR 20469
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MNEXSPIKE (COVID-19 Vaccine, mRNA) Thursday, April 16, 2026 91 FR 20472
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine) Thursday, April 16, 2026 91 FR 20471
Notice of Approval of Product Under Priority Review Voucher; Material Threat Medical Countermeasure Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine) Thursday, April 16, 2026 91 FR 20467
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) Thursday, April 16, 2026 91 FR 20460
Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant Thursday, April 16, 2026 91 FR 20350
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators Thursday, April 16, 2026 91 FR 20352
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion Thursday, April 16, 2026 91 FR 20348
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List Thursday, April 16, 2026 91 FR 20465
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability Monday, March 9, 2026 91 FR 11325
Aspen Global Inc. c/o Lachman Consultant Services, Inc., et al.; Withdrawal of Approval of 46 New Drug Applications Monday, March 9, 2026 91 FR 11321
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 220359, for Camizestrant Tablets; Supplemental New Drug Application (sNDA) 218197/S-004, for Truqap (Capivasertib) Tablets Monday, March 9, 2026 91 FR 11323
Determination of Regulatory Review Period for Purposes of Patent Extension; AUGTYRO Monday, January 5, 2026 91 FR 277
Determination of Regulatory Review Period for Purposes of Patent Extension; BRENZAVVY Monday, January 5, 2026 91 FR 279
Determination of Regulatory Review Period for Purposes of Patent Extension; MEDIBEACON Monday, January 5, 2026 91 FR 282
Determination of Regulatory Review Period for Purposes of Patent Extension; IZERVAY Monday, January 5, 2026 91 FR 280
Determination That MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, January 2, 2026 91 FR 148
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability Friday, January 2, 2026 91 FR 145
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification Monday, June 9, 2025 90 FR 24280
Product-Specific Guidance on Roflumilast; Draft Guidance for Industry; Availability Wednesday, May 21, 2025 90 FR 21777
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Wednesday, May 21, 2025 90 FR 21778
Product-Specific Guidance on Fluticasone Propionate; Draft Guidance for Industry; Availability Wednesday, May 21, 2025 90 FR 21781
Determination of Regulatory Review Period for Purposes of Patent Extension; SKYCLARYS Monday, May 12, 2025 90 FR 20169
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue Monday, May 12, 2025 90 FR 20104
Orthopedic Non-Spinal Bone Plates, Screws, and Washers-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability Friday, November 22, 2024 89 FR 92691
Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers Wednesday, October 30, 2024 89 FR 86239
Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments; Guidance for Industry; Availability Thursday, October 17, 2024 89 FR 83692
Temporary Policies for Compounding Certain Parenteral Drug Products; Guidance for Industry; Availability Thursday, October 17, 2024 89 FR 83691
Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile Friday, September 6, 2024 89 FR 72715
Filing of Food Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene Thursday, January 11, 2024 89 FR 1857
Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Thursday, January 11, 2024 89 FR 1923
Issuance of Priority Review Voucher; Rare Pediatric Disease Product Thursday, January 11, 2024 89 FR 1925
Issuance of Priority Review Voucher; Rare Pediatric Disease Product Thursday, January 11, 2024 89 FR 1924
Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024 Monday, October 23, 2023 88 FR 72767
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2024 Monday, October 23, 2023 88 FR 72763
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Imports and Electronic Import Entries Wednesday, June 28, 2023 88 FR 41964
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability Friday, June 23, 2023 88 FR 41107
Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal Friday, June 23, 2023 88 FR 41108
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Availability Thursday, April 20, 2023 88 FR 24427
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys Thursday, April 20, 2023 88 FR 24423
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Ebola; Availability Thursday, April 20, 2023 88 FR 24425
Medical Devices; Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device Thursday, January 5, 2023 88 FR 751
Medical Devices; Neurological Devices; Classification of the Brain Stimulation Programming Planning Software Thursday, January 5, 2023 88 FR 749
Format and Content of a Risk Evaluation and Mitigation Strategy Document; Guidance for Industry; Availability Thursday, January 5, 2023 88 FR 871
Medical Devices; Orthopedic Devices; Classification of the Bone Indentation Device Thursday, January 5, 2023 88 FR 753
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 Thursday, January 5, 2023 88 FR 745
Authorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availability Friday, December 30, 2022 87 FR 80542
Medical Devices; Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid Friday, December 30, 2022 87 FR 80444
Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee Thursday, December 1, 2022 87 FR 73769
Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program; Draft Guidance for Industry; Availability Wednesday, November 2, 2022 87 FR 66194
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address Thursday, September 29, 2022 87 FR 58957
Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Tuesday, September 13, 2022 87 FR 56059
Merck Sharp & Dohme Corp.; Withdrawal of Approval of New Drug Applications for VIOXX (Rofecoxib) Tablets and Suspension Tuesday, September 13, 2022 87 FR 56061
Prior Notice of Imported Food Questions and Answers (Edition 4); Draft Guidance for Industry; Availability Tuesday, September 13, 2022 87 FR 55932
Determination of Regulatory Review Period for Purposes of Patent Extension; BULKAMID URETHRAL BULKING SYSTEM Tuesday, September 13, 2022 87 FR 56062
Joint Meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Tuesday, September 13, 2022 87 FR 56071
Determination of Regulatory Review Period for Purposes of Patent Extension; REYVOW Tuesday, September 13, 2022 87 FR 56072
Policy for Monkeypox Tests To Address the Public Health Emergency; Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff; Availability Tuesday, September 13, 2022 87 FR 56064
Authorization of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability Monday, August 29, 2022 87 FR 52790
M12 Drug Interaction Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability Monday, August 29, 2022 87 FR 52801
E11A Pediatric Extrapolation; International Council for Harmonisation; Draft Guidance for Industry; Availability Monday, August 29, 2022 87 FR 52788
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential-Questions and Answers; International Council for Harmonisation; Guidance for Industry; Availability Monday, August 29, 2022 87 FR 52786
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations (Revision 1); Draft Guidance for Industry; Availability Friday, August 12, 2022 87 FR 49853
Risk Management Plans To Mitigate the Potential for Drug Shortages; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Extension of Comment Period Tuesday, July 12, 2022 87 FR 41325
Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability Tuesday, July 12, 2022 87 FR 41323
Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications Tuesday, July 12, 2022 87 FR 41322
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Friday, May 20, 2022 87 FR 30961
Howard Stanley Head, Jr.: Final Debarment Order Tuesday, May 17, 2022 87 FR 29867
Proposed Regulations To Establish Tobacco Product Standards for Menthol in Cigarettes and Characterizing Flavors in Cigars: Listening Sessions; Public Meeting; Request for Comments Wednesday, May 4, 2022 87 FR 26311
Tobacco Product Standard for Menthol in Cigarettes Wednesday, May 4, 2022 87 FR 26454
Tobacco Product Standard for Characterizing Flavors in Cigars Wednesday, May 4, 2022 87 FR 26396
Compliance Policy Guides Sec. 335.500; Sec. 310.200; Sec. 393.100; Sec. 398.425; Sec. 394.500; Sec. 300.750; Withdrawal of Guidance Friday, April 22, 2022 87 FR 24174
Drug Products, Including Biological Products, That Contain Nanomaterials; Guidance for Industry; Availability Friday, April 22, 2022 87 FR 24169
Guidance Documents Related to Coronavirus Disease 2019; Availability Friday, April 22, 2022 87 FR 24172
Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry; Availability Friday, April 22, 2022 87 FR 24170
Yvelice Villaman-Bencosme: Final Debarment Order Tuesday, April 19, 2022 87 FR 23184
Bioavailability Studies Submitted in NDAs or INDs-General Considerations; Guidance for Industry; Availability Friday, April 15, 2022 87 FR 22537
Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid Monday, April 11, 2022 87 FR 21018
Medical Device User Fee Amendments; Public Meeting; Request for Comments Thursday, April 7, 2022 87 FR 20436
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment; Guidance for Industry; Availability Thursday, April 7, 2022 87 FR 20431
M7(R2) Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes; International Council for Harmonisation; Draft Guidance for Industry; Availability Thursday, April 7, 2022 87 FR 20435
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Thursday, April 7, 2022 87 FR 20432
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs Thursday, April 7, 2022 87 FR 20420
Determination That PEPCID (Famotidine) for Oral Suspension, 40 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, April 7, 2022 87 FR 20419
Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles Thursday, April 7, 2022 87 FR 20433
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Thursday, April 7, 2022 87 FR 20418
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices Thursday, April 7, 2022 87 FR 20429
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor Tuesday, March 29, 2022 87 FR 17942
Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee; Change of Name and Function; Technical Amendment Wednesday, March 23, 2022 87 FR 16393
Agency Information Collection Activities; Proposed Collection; Comment Request; Abbreviated New Animal Drug Applications Friday, March 18, 2022 87 FR 15436
Determination That MPI DMSA KIDNEY REAGENT (Technetium Tc-99m Succimer Kit), Injectable, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, March 14, 2022 87 FR 14272
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller Monday, March 14, 2022 87 FR 14171
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Thursday, March 10, 2022 87 FR 13736
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Draft Guidance for Industry; Availability Thursday, March 10, 2022 87 FR 13738
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission Friday, February 25, 2022 87 FR 10800
Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products Friday, February 25, 2022 87 FR 10797
Fiscal Year 2022 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments Wednesday, February 16, 2022 87 FR 8843
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program Tuesday, February 8, 2022 87 FR 7190
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug User Fee Program Tuesday, February 8, 2022 87 FR 7186
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Draft Guidance for Industry; Availability Tuesday, February 8, 2022 87 FR 7184
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act Monday, February 7, 2022 87 FR 6869
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations Monday, February 7, 2022 87 FR 6872
Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period Monday, February 7, 2022 87 FR 6875
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability Monday, February 7, 2022 87 FR 6877
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Friday, February 4, 2022 87 FR 6571
Assessment of Pressor Effects of Drugs; Revised Draft Guidance for Industry; Availability Friday, February 4, 2022 87 FR 6577
Medical Devices; General Hospital and Personal Use Devices; Classification of the Alternate Controller Enabled Infusion Pump Friday, February 4, 2022 87 FR 6422
Authorizations of Emergency Use of Certain Drugs and Biological Products During the COVID-19 Pandemic; Availability Friday, February 4, 2022 87 FR 6578
Population Pharmacokinetics; Guidance for Industry; Availability Friday, February 4, 2022 87 FR 6575
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period Friday, January 28, 2022 87 FR 4611
Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Draft Guidance for Industry; Availability Thursday, January 27, 2022 87 FR 4252
Advice About Eating Fish: For Those Who Might Become or Are Pregnant or Breastfeeding and Children Ages 1-11 Years, From the Environmental Protection Agency and Food and Drug Administration; Revised Fish Advice; Availability Friday, October 29, 2021 86 FR 60053
Generic Drug User Fee Amendments; Public Meeting; Request for Comments Friday, October 29, 2021 86 FR 60049
Securing Updated and Necessary Statutory Evaluations Timely; Proposal To Withdraw or Repeal Friday, October 29, 2021 86 FR 59906
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Guidance for Industry; Availability Thursday, September 30, 2021 86 FR 54206
Determination of Regulatory Review Period for Purposes of Patent Extension; Zephyr Endobronchial Valve Implant Wednesday, July 7, 2021 86 FR 35807
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Friday, July 2, 2021 86 FR 35303
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications; Draft Guidance for Industry; Availability Friday, July 2, 2021 86 FR 35304
Providing Regulatory Submissions in Alternate Electronic Format; Guidance for Industry; Availability Friday, July 2, 2021 86 FR 35302
Evaluating Cancer Drugs in Patients With Central Nervous System Metastases; Guidance for Industry; Availability Friday, July 2, 2021 86 FR 35305
Issuance of Priority Review Voucher; Rare Pediatric Disease Product Friday, July 2, 2021 86 FR 35307
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability Friday, November 20, 2020 85 FR 74345
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Wednesday, October 28, 2020 85 FR 68339
Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2021 Proposed Guidance Development Monday, October 19, 2020 85 FR 66333
Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs; Public Meeting; Request for Comments Tuesday, October 13, 2020 85 FR 64481
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Thursday, August 20, 2020 85 FR 51453
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act and Associated Fees Thursday, August 20, 2020 85 FR 51442
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Surveys Thursday, August 20, 2020 85 FR 51449
Determination of Regulatory Review Period for Purposes of Patent Extension; OXERVATE Thursday, August 20, 2020 85 FR 51446
Public Meeting on the Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program-Summer 2020; Public Meeting; Request for Comments Thursday, August 20, 2020 85 FR 51445
Electronic Study Data Submission; Data Standards; Support and Requirement Begin for Study Data Tabulation Model Version 1.7 Implementation Guide 3.3 and for Define-Extensible Markup Language Version 2.1; Requirement Ends for Study Data Tabulation Model Version 1.3 Implementation Guide 3.1.3; Correction Thursday, August 20, 2020 85 FR 51450
New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation; Public Workshop; Request for Comments Thursday, August 13, 2020 85 FR 49377
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices Thursday, August 13, 2020 85 FR 49379
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures Thursday, August 13, 2020 85 FR 49381
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations Wednesday, August 12, 2020 85 FR 48705
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate Wednesday, August 12, 2020 85 FR 48650
New Animal Drugs; Withdrawal of Approval of Abbreviated New Animal Drug Application Tuesday, July 28, 2020 85 FR 45311
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor Tuesday, July 28, 2020 85 FR 45306
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments Monday, June 8, 2020 85 FR 35096
March 10 Through April 30, 2020, Public Meetings; Postponement, Cancellation, or Remote Only Thursday, March 19, 2020 85 FR 15789
Brenda Elise Edwards: Final Debarment Order Thursday, March 19, 2020 85 FR 15791
Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of Comment Period Thursday, March 19, 2020 85 FR 15788
Pan American Laboratories, LLC, et al.; Withdrawal of Approval of Three New Drug Applications Tuesday, March 17, 2020 85 FR 15192
Matthew Dailey: Final Debarment Order Tuesday, March 17, 2020 85 FR 15193
Jagen D. Lewicki: Final Debarment Order Tuesday, March 17, 2020 85 FR 15190
Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503 Tuesday, March 17, 2020 85 FR 15188
Zhang Xiao Dong: Final Debarment Order Tuesday, March 17, 2020 85 FR 15191
Determination That Potassium Chloride in 5% Dextrose and 0.225% Sodium Chloride Injection, 5 Milliequivalents, 10 Milliequivalents, 15 Milliequivalents, 20 Milliequivalents, 30 Milliequivalents, and 40 Milliequivalents, in Plastic Containers, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Tuesday, March 17, 2020 85 FR 15194
Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting Friday, March 13, 2020 85 FR 14681
Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments Friday, March 6, 2020 85 FR 13165
Training Program for Regulatory Project Managers; Information Available to Industry Friday, March 6, 2020 85 FR 13164
Best Practices in Drug and Biological Product Postmarket Safety Surveillance for Food and Drug Administration Staff; Draft Document; Reopening of Comment Period Friday, March 6, 2020 85 FR 13170
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey Friday, March 6, 2020 85 FR 13171
Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior Friday, March 6, 2020 85 FR 13312
Long Term Follow-Up After Administration of Human Gene Therapy Products; Guidance for Industry; Availability Thursday, January 30, 2020 85 FR 5452
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations; Draft Guidance for Industry; Availability Thursday, January 30, 2020 85 FR 5445
Human Gene Therapy for Rare Diseases; Guidance for Industry; Availability Thursday, January 30, 2020 85 FR 5451
Human Gene Therapy for Retinal Disorders; Guidance for Industry; Availability Thursday, January 30, 2020 85 FR 5454
Human Gene Therapy for Hemophilia; Guidance for Industry; Availability Thursday, January 30, 2020 85 FR 5444
Chemistry, Manufacturing, and Control Information for Human Gene Therapy Investigational New Drug Applications; Guidance for Industry; Availability Thursday, January 30, 2020 85 FR 5447
Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Guidance for Industry; Availability Thursday, January 30, 2020 85 FR 5448
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Thursday, January 30, 2020 85 FR 5446
Importation of Prescription Drugs Monday, December 23, 2019 84 FR 70796
Qualification Process for Drug Development Tools; Draft Guidance for Industry; Availability Monday, December 16, 2019 84 FR 68460
Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting; Request for Comments Friday, October 18, 2019 84 FR 55971
Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Tuesday, October 1, 2019 84 FR 52111
Fee for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2020 Monday, September 30, 2019 84 FR 51597
Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal Tuesday, August 13, 2019 84 FR 40069
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2020 Friday, August 2, 2019 84 FR 37896
Determining the Number of Employees for Purposes of the “Small Business” Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food): Guidance for Industry; Availability Friday, June 21, 2019 84 FR 29054
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework; Draft Guidance for Industry; Availability Friday, June 21, 2019 84 FR 29211
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe: Notification Procedure Friday, June 21, 2019 84 FR 29216
Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing Friday, June 21, 2019 84 FR 29112
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Amendment of Notice Friday, June 21, 2019 84 FR 29212
Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Oncology Indications in Direct-to-Consumer Television Advertising Friday, June 21, 2019 84 FR 29213
Agency Information Collection Activities; Proposed Collection; Comment Request; Threshold of Regulation for Substances Used in Food-Contact Articles Friday, June 21, 2019 84 FR 29209
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability Tuesday, May 7, 2019 84 FR 19923
Agency Information Collection Activities; Proposed Collection; Comment Request; Manufactured Food Regulatory Program Standards Wednesday, April 17, 2019 84 FR 16020
Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products Tuesday, April 2, 2019 84 FR 12505
Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment Tuesday, April 2, 2019 84 FR 12490
Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue Wednesday, March 6, 2019 84 FR 7991
Determination of Regulatory Review Period for Purposes of Patent Extension; ZEJULA Tuesday, February 12, 2019 84 FR 3470
Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications Tuesday, February 12, 2019 84 FR 3467
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Assessment of Combination Product Review Practices Tuesday, February 12, 2019 84 FR 3459
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Applications Tuesday, February 12, 2019 84 FR 3462
Determination of Regulatory Review Period for Purposes of Patent Extension; EUCRISA Tuesday, February 12, 2019 84 FR 3458
Agency Information Collection Activities; Proposed Collection; Comment Request; Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act Tuesday, February 12, 2019 84 FR 3460
Su-Chiao Kuo: Debarment Order Tuesday, December 11, 2018 83 FR 63656
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations Friday, December 7, 2018 83 FR 63179
Bone, Reproductive and Urologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Friday, November 30, 2018 83 FR 61650
Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Announcement of Public Meeting; Request for Comments Thursday, November 29, 2018 83 FR 61385
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey of Current Manufacturing Practices for the Cosmetics Industry Tuesday, November 20, 2018 83 FR 58582
Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments Tuesday, November 20, 2018 83 FR 58574
Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council for Harmonisation E2B(R3) Standards; Public Meetings; Request for Comments Friday, November 16, 2018 83 FR 57732
Drug Development Tool Process Under the 21st Century Cures Act and Prescription Drug User Fee Act VI; Public Meeting; Request for Comments Tuesday, November 13, 2018 83 FR 56347
Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and Food and Drug Administration Staff; Availability Tuesday, November 6, 2018 83 FR 55551
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Meprobamate Test System Thursday, November 1, 2018 83 FR 54875
Determination of Regulatory Review Period for Purposes of Patent Extension; REBINYN Friday, October 26, 2018 83 FR 54112
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products Tuesday, October 23, 2018 83 FR 53478
Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device Friday, October 19, 2018 83 FR 52966
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs Friday, October 19, 2018 83 FR 53065
Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms Friday, October 19, 2018 83 FR 52973
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease; Guidance for Industry; Availability Tuesday, October 16, 2018 83 FR 52222
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Thursday, October 11, 2018 83 FR 51464
Food Additives Permitted for Direct Addition to Food for Human Consumption; Styrene Tuesday, October 9, 2018 83 FR 50487
The Special 510(k) Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Friday, September 28, 2018 83 FR 49097
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2019 Wednesday, September 26, 2018 83 FR 48636
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Tuesday, September 18, 2018 83 FR 47178
Determination of Status as a Qualified Facility Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; Guidance for Industry; Availability Monday, September 17, 2018 83 FR 46878
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program Wednesday, September 12, 2018 83 FR 46166
Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee Thursday, September 6, 2018 83 FR 45249
Allergic Rhinitis: Developing Drug Products for Treatment; Guidance for Industry; Availability Thursday, September 6, 2018 83 FR 45259
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Development of FDA Communications Tuesday, September 4, 2018 83 FR 44888
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations Tuesday, September 4, 2018 83 FR 44884
Advisory Committee; Cardiovascular and Renal Drugs Advisory Committee; Renewal Tuesday, September 4, 2018 83 FR 44887
Advisory Committee; Endocrinologic and Metabolic Drugs Advisory Committee, Renewal Tuesday, September 4, 2018 83 FR 44888
Physiologically Based Pharmacokinetic Analyses-Format and Content; Guidance for Industry; Availability Tuesday, September 4, 2018 83 FR 44883
Food for Human Consumption; Export Certificates; Food and Drug Administration Food Safety Modernization Act of 2011; Certification Fees Tuesday, September 4, 2018 83 FR 44890
Complex Innovative Designs Pilot Meeting Program Thursday, August 30, 2018 83 FR 44274
Determination That DITROPAN XL (Oxybutynin Chloride) Extended Release Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Wednesday, August 22, 2018 83 FR 42512
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority Friday, August 3, 2018 83 FR 38151
Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications; Temporary Stay of Effective Date Monday, July 30, 2018 83 FR 36604
Determination That Metaxalone Tablets, 640 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, July 27, 2018 83 FR 35648
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry; Availability Friday, July 27, 2018 83 FR 35657
E17 General Principles for Planning and Design of Multiregional Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability Thursday, July 19, 2018 83 FR 34139
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Wednesday, July 11, 2018 83 FR 32134
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications Tuesday, July 3, 2018 83 FR 31152
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures; Formal Evidentiary Public Hearing Friday, June 29, 2018 83 FR 30736
Medical Devices; Immunology and Microbiology Devices; Classification of the Next Generation Sequencing Based Tumor Profiling Test Friday, June 22, 2018 83 FR 28994
The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; Availability Friday, June 15, 2018 83 FR 27894
Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal Friday, June 15, 2018 83 FR 27895
Limited Population Pathway for Antibacterial and Antifungal Drugs; Draft Guidance for Industry; Availability Wednesday, June 13, 2018 83 FR 27616
Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; Proposed List Under the 21st Century Cures Act Wednesday, June 13, 2018 83 FR 27609
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities-Questions and Answers; Guidance for Industry; Availability Wednesday, June 13, 2018 83 FR 27605
Regulation of Flavors in Tobacco Products; Extension of Comment Period Friday, June 8, 2018 83 FR 26618
Listing of Color Additives Subject to Certification; D&C Black No. 4 Thursday, June 7, 2018 83 FR 26356
Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax; Guidance for Industry; Availability Thursday, May 24, 2018 83 FR 24128
Acne Vulgaris: Establishing Effectiveness of Drugs Intended for Treatment; Guidance for Industry; Availability Tuesday, May 22, 2018 83 FR 23689
Establishing Effectiveness for Drugs Intended To Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders; Guidance for Industry; Availability Monday, May 21, 2018 83 FR 23461
Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal Monday, May 21, 2018 83 FR 23467
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigation of Consumer Perceptions of Expressed Modified Risk Claims Monday, May 21, 2018 83 FR 23464
Documenting Electronic Data Files and Statistical Analysis Programs; Draft Guidance for Industry; Availability Monday, May 21, 2018 83 FR 23468
Mary C. Holloway; Order Revoking a Proposed Order of Debarment Monday, May 21, 2018 83 FR 23469
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability Monday, May 14, 2018 83 FR 22193

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