Agency Archive

Food and Drug Administration

Recent Federal Register documents and issues associated with this agency.

Recent Documents

Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Wednesday, May 6, 2026 91 FR 24548
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha) Wednesday, May 6, 2026 91 FR 24549
Modification of Certain Terminology in Title 21 Wednesday, May 6, 2026 91 FR 24380
Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals Wednesday, May 6, 2026 91 FR 24346
Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device Wednesday, May 6, 2026 91 FR 24343
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples Wednesday, May 6, 2026 91 FR 24341
Agency Information Collection Activities; Proposed Collection; Comment Request; National Youth Tobacco Survey Monday, May 4, 2026 91 FR 23995
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Friday, May 1, 2026 91 FR 23431
Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments Friday, May 1, 2026 91 FR 23426
Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments Friday, May 1, 2026 91 FR 23424
Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments Friday, May 1, 2026 91 FR 23427
Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions Friday, May 1, 2026 91 FR 23357
ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing Thursday, April 30, 2026 91 FR 23278
Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, April 30, 2026 91 FR 23276
Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter Thursday, April 30, 2026 91 FR 23161
Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System Thursday, April 30, 2026 91 FR 23163
Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device Thursday, April 30, 2026 91 FR 23166
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice Thursday, April 30, 2026 91 FR 23276
Determination FENOGLIDE (Fenofibrate) Tablets, 40 Milligrams and 120 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Thursday, April 30, 2026 91 FR 23288
Advisory Committee; Pharmacy Compounding Advisory Committee; Renewal Thursday, April 30, 2026 91 FR 23275
Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies Thursday, April 30, 2026 91 FR 23273
AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program; Request for Information Wednesday, April 29, 2026 91 FR 23100
Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewal Monday, April 27, 2026 91 FR 22539
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-United States (U.S.) 2026-2027 Formula for COVID-19 Vaccine Composition Monday, April 27, 2026 91 FR 22542
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability Friday, April 24, 2026 91 FR 22155
Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications Friday, April 24, 2026 91 FR 22156
Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments; Amendment Thursday, April 23, 2026 91 FR 21822
Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List Additions and Request for Comments Thursday, April 23, 2026 91 FR 21824
Kimberly Schaff Kiehl: Final Debarment Order Thursday, April 23, 2026 91 FR 21823
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System Wednesday, April 22, 2026 91 FR 21376
Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement Wednesday, April 22, 2026 91 FR 21381
Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia Wednesday, April 22, 2026 91 FR 21383
Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test Wednesday, April 22, 2026 91 FR 21379
Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability Monday, April 20, 2026 91 FR 21000
Potential New Indication for Testosterone Replacement Therapy Monday, April 20, 2026 91 FR 21002
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Monday, April 20, 2026 91 FR 21003
Authorization of Emergency Use for Four Animal Drugs for the Treatment of New World Screwworm; Availability Friday, April 17, 2026 91 FR 20661
Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees Friday, April 17, 2026 91 FR 20659
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed Friday, April 17, 2026 91 FR 20693
Animal Drug User Fee Act; Public Meeting; Request for Comments Friday, April 17, 2026 91 FR 20695
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments Friday, April 17, 2026 91 FR 20691
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
Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments Wednesday, April 15, 2026 91 FR 20170
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry; Availability Wednesday, April 15, 2026 91 FR 20173
Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments Wednesday, April 15, 2026 91 FR 20171
Determination That BILTRICIDE (Praziquantel) Oral Tablet, 600 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, April 13, 2026 91 FR 18866
Notice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Drug Application for TRADIPITANT Capsules Tuesday, March 31, 2026 91 FR 16007
Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments Tuesday, March 31, 2026 91 FR 16006
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Advisory Committees Monday, March 23, 2026 91 FR 13852
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Associated With Animal Drug and Animal Generic Drug User Fees Monday, March 23, 2026 91 FR 13854
Commissioner's National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments Monday, March 23, 2026 91 FR 13849
Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications-Considerations Related to Youth Risk; Draft Guidance for Industry; Availability Wednesday, March 11, 2026 91 FR 11980
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
Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments Tuesday, March 3, 2026 91 FR 10397
Jeremy Spencer Brown: Final Debarment Order Thursday, February 12, 2026 91 FR 6643
Determination of Regulatory Review Period for Purposes of Patent Extension; RYZNEUTA Tuesday, January 27, 2026 91 FR 3513
Determination of Regulatory Review Period for Purposes of Patent Extension; EXBLIFEP Tuesday, January 27, 2026 91 FR 3518
Determination of Regulatory Review Period for Purposes of Patent Extension; REZDIFFRA Tuesday, January 27, 2026 91 FR 3507
Determination of Regulatory Review Period for Purposes of Patent Extension; BIMZELX Tuesday, January 27, 2026 91 FR 3515
Agency Information Collection Activities; Proposed Collection; Comment Request; Medication Guides for Prescription Drug Products Tuesday, January 27, 2026 91 FR 3511
Determination of Regulatory Review Period for Purposes of Patent Extension; IMAAVY Tuesday, January 27, 2026 91 FR 3517
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
Cross-Center Master Files: Where To Submit; Draft Guidance for Industry; Availability Wednesday, November 26, 2025 90 FR 54330
Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device Wednesday, November 26, 2025 90 FR 54232
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath Wednesday, November 26, 2025 90 FR 54230
Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide Wednesday, September 3, 2025 90 FR 42535
Determination That NUTRACORT (Hydrocortisone) Topical Gel, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Wednesday, September 3, 2025 90 FR 42590
Biomin GmbH; Filing of Food Additive Petition (Animal Use) Wednesday, September 3, 2025 90 FR 42550
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories Wednesday, September 3, 2025 90 FR 42591
General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Wednesday, September 3, 2025 90 FR 42588
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Medical Devices; Foreign Letters of Approval Wednesday, September 3, 2025 90 FR 42591
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Food Safety and Nutrition Survey Wednesday, September 3, 2025 90 FR 42593
Determination That Four Heparin Sodium In Sodium Chloride In Plastic Container (Heparin Sodium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Tuesday, August 26, 2025 90 FR 41572
Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS Tuesday, August 26, 2025 90 FR 41579
Determination of Regulatory Review Period for Purposes of Patent Extension; VORANIGO Tuesday, August 26, 2025 90 FR 41583
Determination of Regulatory Review Period for Purposes of Patent Extension; ZUNVEYL Tuesday, August 26, 2025 90 FR 41574
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substances Generally Recognized as Safe (GRAS): Notifications and Convening Panels Tuesday, August 26, 2025 90 FR 41579
Determination of Regulatory Review Period for Purposes of Patent Extension; NEMLUVIO Tuesday, August 26, 2025 90 FR 41581
Determination of Regulatory Review Period for Purposes of Patent Extension; LUMISIGHT Tuesday, August 26, 2025 90 FR 41567
Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension Thursday, August 7, 2025 90 FR 38084
Agency Information Collection Activities; Proposed Collection; Comment Request; Collection of Conflict-of-Interest Information for Participation in Food and Drug Administration Non-Employee Fellowship and Traineeship Programs Thursday, August 7, 2025 90 FR 38154
Agency Information Collection Activities; Proposed Collection; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products Thursday, August 7, 2025 90 FR 38155
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices Thursday, August 7, 2025 90 FR 38151
Food Standards of Identity Modernization; Pasteurized Orange Juice Wednesday, August 6, 2025 90 FR 37817
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correction Wednesday, August 6, 2025 90 FR 37793
Determination That ROXICET (Oxycodone Hydrochloride and Acetaminophen) Tablet, 5 Milligrams and 325 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, August 4, 2025 90 FR 36441
Determination That HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (Heparin Sodium) Injectable, 200 Units/100 Milliliters, and Two Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, August 4, 2025 90 FR 36442
Prescription Drug User Fee Act VII; Independent Assessment of Communication Through Product Quality Information Requests During Application Review; Final Report; Availability; Reopening of Comment Period Monday, August 4, 2025 90 FR 36443
Teva Branded Pharmaceutical Products R&D, Inc., et al.; Withdrawal of Approval of 39 New Drug Applications Monday, August 4, 2025 90 FR 36440
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2026 Wednesday, July 30, 2025 90 FR 35883
Biosimilar User Fee Rates for Fiscal Year 2026 Wednesday, July 30, 2025 90 FR 35872
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2026 Wednesday, July 30, 2025 90 FR 35906
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2026 Wednesday, July 30, 2025 90 FR 35910
Prescription Drug User Fee Rates for Fiscal Year 2026 Wednesday, July 30, 2025 90 FR 35866
Medical Device User Fee Rates for Fiscal Year 2026 Wednesday, July 30, 2025 90 FR 35895
Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2026 Wednesday, July 30, 2025 90 FR 35863
Tobacco Products Scientific Advisory Committee; Notice of Meeting Wednesday, July 30, 2025 90 FR 35894
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice-Establishment of Public Docket; Request for Comments-Dermal Fillers Wednesday, July 30, 2025 90 FR 35910
Arthritis Advisory Committee; Termination Wednesday, July 30, 2025 90 FR 35876
Agency Information Collection Activities; Proposed Collection; Comment Request; Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and Issue Certifications Friday, June 27, 2025 90 FR 27625
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of February 15, 2007 Friday, June 27, 2025 90 FR 27632
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Generally Recognized as Safe: Notifications and Convening Panels Friday, June 27, 2025 90 FR 27642
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 Friday, June 27, 2025 90 FR 27617
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed Friday, June 27, 2025 90 FR 27630
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission Friday, June 27, 2025 90 FR 27640
Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Friday, June 27, 2025 90 FR 27619
Agency Information Collection Activities; Proposed Collection; Comment Request; Exemptions From Substantial Equivalence Requirements for Tobacco Products Friday, June 27, 2025 90 FR 27623
Agency Information Collection Activities; Proposed Collection; Comment Request; Production, Storage, and Transportation of Shell Eggs (Preventing Salmonella Enteritidis) Friday, June 27, 2025 90 FR 27614
June 27, 2025-Agency Information Collection Activities; Proposed Collection; Comment Request; Meetings With Industry and Investigators on the Research and Development of Tobacco Products Friday, June 27, 2025 90 FR 27636
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases-Questions and Answers; Guidance for Industry; Availability Friday, June 27, 2025 90 FR 27621
Change in Federal Payment and Collection Options Friday, June 27, 2025 90 FR 27639
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
Determination That EPINEPHRINE (Epinephrine) Solution, 1 Milligram/Milliliter, Prefilled Syringe for Intravenous Use, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Monday, June 2, 2025 90 FR 23341
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver; International Council for Harmonisation; Draft Guidance for Industry; Availability Monday, June 2, 2025 90 FR 23339
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fluid Monday, June 2, 2025 90 FR 23281
Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System Monday, June 2, 2025 90 FR 23283
Replacing Color Additives in Approved or Marketed Drug Products; Draft Guidance for Industry; Availability Friday, May 30, 2025 90 FR 23061
Evan Asher Field: Final Debarment Order Friday, May 30, 2025 90 FR 23057
Meda AB and B. Braun Medical, Inc.; Withdrawal of Approval of Two New Drug Applications Friday, May 30, 2025 90 FR 23055
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System Friday, May 30, 2025 90 FR 22848
Determination That COREG CR (Carvedilol Phosphate) Extended-Release Capsules, 10 Milligrams, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Friday, May 30, 2025 90 FR 23056
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability Friday, May 30, 2025 90 FR 23056
Determination of Regulatory Review Period for Purposes of Patent Extension; LOQTORZI Friday, May 30, 2025 90 FR 23059
Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request for Information; Extension of Comment Period; Correction Thursday, May 29, 2025 90 FR 22735
Listing of Color Additives; Myoglobin; Confirmation of Effective Date Thursday, May 29, 2025 90 FR 22627
Revocation of Four Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability Thursday, May 29, 2025 90 FR 22727
Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period Thursday, May 29, 2025 90 FR 22675
Carlton Reico Mallard Jr.: Final Debarment Order Thursday, May 29, 2025 90 FR 22736
Justin Cole Henry: Final Debarment Order Thursday, May 29, 2025 90 FR 22734
Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test Thursday, May 29, 2025 90 FR 22629
Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia Thursday, May 29, 2025 90 FR 22634
Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents Thursday, May 29, 2025 90 FR 22632
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System Thursday, May 29, 2025 90 FR 22627
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability Thursday, May 29, 2025 90 FR 22737
Electronic Submission Template for Medical Device Q-Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Thursday, May 29, 2025 90 FR 22742
Second Annual Animal Drug User Fee Educational Conference; Public Meeting Thursday, May 29, 2025 90 FR 22739
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
Revocation of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability Wednesday, May 21, 2025 90 FR 21782
Dihydropyrimidine Dehydrogenase Deficiency and the Use of Fluoropyrimidine Chemotherapy Drugs; Establishment of a Public Docket; Request for Comments Tuesday, May 20, 2025 90 FR 21483
Food Additives Permitted in Feed and Drinking Water of Animals; Selenium Monday, May 19, 2025 90 FR 21219
Determination of Regulatory Review Period for Purposes of Patent Extension; ELAHERE Monday, May 19, 2025 90 FR 21311
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments Monday, May 19, 2025 90 FR 21315
Determination of Regulatory Review Period for Purposes of Patent Extension; LAMZEDE Monday, May 12, 2025 90 FR 20179
Determination of Regulatory Review Period for Purposes of Patent Extension; NGENLA Monday, May 12, 2025 90 FR 20172
Determination of Regulatory Review Period for Purposes of Patent Extension; JAYPIRCA Monday, May 12, 2025 90 FR 20175
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
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting Thursday, May 8, 2025 90 FR 19490
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2025-2026 Formula for COVID-19 Vaccines for Use in the United States Thursday, May 8, 2025 90 FR 19494
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 761309/S-001, for COLUMVI (glofitamab) Injection; Supplemental Biologics License Application 761145/S-029, for DARZALEX FASPRO (daratumumab and hyaluronidase) Injection; New Drug Application 215793, for (mitomycin) Intravesical Solution; Supplemental New Drug Application 211651/S-013, for TALZENNA (talazoparib) Capsules Thursday, May 8, 2025 90 FR 19488
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Microbiological Testing and Corrective Measures for Bottled Water Friday, May 2, 2025 90 FR 18859
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability Thursday, March 20, 2025 90 FR 13164
Jonathan Corbett Cosie: Final Debarment Order Thursday, March 13, 2025 90 FR 11984
Harpreet Singh: Final Debarment Order Thursday, March 13, 2025 90 FR 11986
E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Reopening of the Comment Period Thursday, March 13, 2025 90 FR 11985
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; Gomekli (mirdametinib) Thursday, March 13, 2025 90 FR 11992
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” Tuesday, February 25, 2025 90 FR 10592
Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal Friday, January 10, 2025 90 FR 2008
National Antimicrobial Resistance Monitoring System 2026-2030 Strategic Plan; Request for Comments Friday, January 10, 2025 90 FR 2007
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor) Friday, January 10, 2025 90 FR 2006
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; CRENESSITY (crinecerfont) Friday, January 10, 2025 90 FR 2008
Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee Friday, January 10, 2025 90 FR 2009
Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee Monday, January 6, 2025 90 FR 655
Food Contact Notifications That Are No Longer Effective Monday, January 6, 2025 90 FR 653
Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability Monday, January 6, 2025 90 FR 563
Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Files Monday, December 30, 2024 89 FR 106493
Fosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction Monday, December 30, 2024 89 FR 106522
Determination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIAN Monday, December 30, 2024 89 FR 106505
E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Availability Monday, December 30, 2024 89 FR 106519
Determination of Regulatory Review Period for Purposes of Patent Extension; VEOZAH Monday, December 30, 2024 89 FR 106496
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Request for Comments-Dermal Fillers Monday, December 30, 2024 89 FR 106497
E11A Pediatric Extrapolation; International Council for Harmonisation; Guidance for Industry; Availability Monday, December 30, 2024 89 FR 106515
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Shortages Data Collection Monday, December 30, 2024 89 FR 106514
Determination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ER Monday, December 30, 2024 89 FR 106507
Determination of Regulatory Review Period for Purposes of Patent Extension; NEXOBRID Monday, December 30, 2024 89 FR 106508
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Process (Evaluation of Automatic Class III Designation) Monday, December 30, 2024 89 FR 106512
Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence Friday, December 27, 2024 89 FR 105613
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” Friday, December 27, 2024 89 FR 106064
Export Lists for Human Food: Request for Information; Extension of Comment Period Thursday, December 26, 2024 89 FR 105059
Privacy Act of 1974; System of Records Thursday, December 26, 2024 89 FR 105054
Monterey Mushrooms, LLC; Filing of Food Additive Petition Thursday, December 26, 2024 89 FR 104908
Statement of Organization, Functions, and Delegations of Authority Thursday, December 26, 2024 89 FR 105052
Nonprescription Drug Product With an Additional Condition for Nonprescription Use Thursday, December 26, 2024 89 FR 105288
Statement of Organization, Functions, and Delegations of Authority Monday, December 23, 2024 89 FR 104549
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Related Collections of Information Friday, December 20, 2024 89 FR 104188
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices Wednesday, December 18, 2024 89 FR 102910
Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability Thursday, December 12, 2024 89 FR 100508
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-Extended-Release/Long-Acting Opioid Analgesic Postmarketing Requirement Monday, December 9, 2024 89 FR 97625
Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability Friday, December 6, 2024 89 FR 97011
Food and Drug Administration Report and Plan on Best Practices for Guidance; Availability Tuesday, December 3, 2024 89 FR 95799
Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators Friday, November 29, 2024 89 FR 94735
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications Monday, November 25, 2024 89 FR 92943
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
Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; Availability Friday, November 15, 2024 89 FR 90296
Patient-Focused Drug Development: Workshop To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop; Request for Comments Thursday, November 14, 2024 89 FR 90018
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
Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Guidance for Industry; Availability Friday, October 25, 2024 89 FR 85217
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 Friday, October 25, 2024 89 FR 85219
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals Friday, October 25, 2024 89 FR 85217
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Animal Food Thursday, October 24, 2024 89 FR 84895
Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales and Distribution Thursday, October 24, 2024 89 FR 84887
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion Thursday, October 24, 2024 89 FR 84889
Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Guidance for Industry; Availability Thursday, October 24, 2024 89 FR 84819
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments Thursday, October 24, 2024 89 FR 84894
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
Endosseous Dental Implants and Endosseous Dental Implant Abutments-Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff; Availability Tuesday, October 15, 2024 89 FR 83019
Revocation of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availability Tuesday, October 15, 2024 89 FR 83021
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab) Friday, October 11, 2024 89 FR 82612
Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2025 Proposed Guidance Development Friday, October 11, 2024 89 FR 82612
Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence; Program Announcement Wednesday, October 2, 2024 89 FR 80257
Determination That AUGMENTIN XR (Amoxicillin; Clavulanate Potassium) Extended-Release Tablets, 1 Gram; Equivalent to 62.5 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Wednesday, October 2, 2024 89 FR 80258
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 210934 for Sotagliflozin Oral Tablet Wednesday, October 2, 2024 89 FR 80259
Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry; Availability Wednesday, October 2, 2024 89 FR 80255
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 125586/546 From AstraZeneca AB for Andexxa (Coagulation Factor Xa (Recombinant), Inactivated -zhzo); November 21, 2024 Wednesday, October 2, 2024 89 FR 80250
Determination of Regulatory Review Period for Purposes of Patent Extension; ZAVZPRET Wednesday, September 25, 2024 89 FR 78309
Determination of Regulatory Review Period for Purposes of Patent Extension; DAYBUE Wednesday, September 25, 2024 89 FR 78312
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices Wednesday, September 25, 2024 89 FR 78265
Determination of Regulatory Review Period for Purposes of Patent Extension; FRUZAQLA Wednesday, September 25, 2024 89 FR 78307
Determination of Regulatory Review Period for Purposes of Patent Extension; ELUCIREM Wednesday, September 25, 2024 89 FR 78315
Live Biotherapeutic Products To Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants; Public Workshop; Request for Comments Wednesday, September 25, 2024 89 FR 78316
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority Wednesday, September 25, 2024 89 FR 78313
Determination of Regulatory Review Period for Purposes of Patent Extension; JESDUVROQ Wednesday, September 25, 2024 89 FR 78310
Determination of Regulatory Review Period for Purposes of Patent Extension; OMLONTI Wednesday, September 25, 2024 89 FR 78306
Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugs Thursday, September 19, 2024 89 FR 76853
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a Thursday, September 19, 2024 89 FR 76851
Allergan, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications Thursday, September 19, 2024 89 FR 76849

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