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federal register · 2024

How many rules and notices did Food and Drug Administration publish in 2024?

In 2024 Food and Drug Administration published 748 Federal Register documents: 66 final rules, 30 proposed rules, 652 notices; 6 marked significant. Busiest month: 2024-09.

DOCUMENTS: 748FINAL RULES: 66PROPOSED: 30

Cite: FACTANKER, https://factanker.com/federal-register/food-and-drug-administration/2024

What stands out

In 2024 Food and Drug Administration published 748 Federal Register documents: 66 final rules, 30 proposed rules, 652 notices; 6 marked significant. Busiest month: 2024-09.

By month

MonthDocumentsFinal rulesProposedNotices
2024-01492245
2024-02716164
2024-03774568
2024-04492245
2024-05557543
2024-06594154
2024-07763271
2024-08657355
2024-099421568
2024-10495143
2024-11411040
2024-12634356

Documents, 2024

The 400 most recent; the JSON view carries the same list.

PublishedTypeDocumentEvidence
Dec 31, 2024NoticeFlamingo Pharmaceuticals Ltd.; Withdrawal of Approval of Two Abbreviated New Drug Applicationsrecord →
Dec 31, 2024NoticeAdvisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewalrecord →
Dec 31, 2024NoticeEvaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Reopening of the Comment Periodrecord →
Dec 31, 2024RuleUniform Compliance Date for Food Labeling Regulationsrecord →
Dec 30, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; De Novo Classification Prorecord →
Dec 30, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; NEXOBRIDrecord →
Dec 30, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; XTAMPZA ERrecord →
Dec 30, 2024NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approval; Shortages Data Collectionrecord →
Dec 30, 2024NoticeE11A Pediatric Extrapolation; International Council for Harmonisation; Guidance for Industry; Availabilityrecord →
Dec 30, 2024NoticeM15 General Principles for Model-Informed Drug Development; International Council for Harmonisation; Draft Guidance for Industry; Availabilirecord →
Dec 30, 2024NoticeGeneral and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Requrecord →
Dec 30, 2024NoticeProtocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availabilityrecord →
Dec 30, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; OMISIRGErecord →
Dec 30, 2024NoticeTransfer of Regulatory Responsibility From the Center for Devices and Radiological Health to the Center for Biologics Evaluation and Researcrecord →
Dec 30, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VEOZAHrecord →
Dec 30, 2024NoticeRequest for Nominations for Individuals and Consumer Organizations for Advisory Committeesrecord →
Dec 30, 2024NoticeRequest for Nominations of Individuals and Industry Organizations for the Patient Engagement Advisory Committeerecord →
Dec 30, 2024NoticeE6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Availabilityrecord →
Dec 30, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ROCTAVIANrecord →
Dec 30, 2024NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approval; National Agriculture and Food Defense Strecord →
Dec 30, 2024NoticeCombined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document; Draft Guidance for Industry; Availabrecord →
Dec 30, 2024NoticeFosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correctionrecord →
Dec 30, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug and Veterinary Master Filesrecord →
Dec 30, 2024NoticeCardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Nerecord →
Dec 27, 2024RuleFood Labeling: Nutrient Content Claims; Definition of Term “Healthy”record →
Dec 27, 2024Proposed RuleTesting Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Productsrecord →
Dec 27, 2024NoticeModifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependencerecord →
Dec 26, 2024RuleNonprescription Drug Product With an Additional Condition for Nonprescription Userecord →
Dec 26, 2024NoticeStatement of Organization, Functions, and Delegations of Authorityrecord →
Dec 26, 2024Proposed RuleMonterey Mushrooms, LLC; Filing of Food Additive Petitionrecord →
Dec 26, 2024NoticePrivacy Act of 1974; System of Recordsrecord →
Dec 26, 2024NoticeExport Lists for Human Food: Request for Information; Extension of Comment Periodrecord →
Dec 23, 2024NoticeStatement of Organization, Functions, and Delegations of Authorityrecord →
Dec 20, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Producers record →
Dec 19, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request Data To Support Social and record →
Dec 19, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Food Additives Intended for Use in Animal Food, Food Additivrecord →
Dec 19, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Interstate Shellfish Dealer's Certificate and Participation record →
Dec 19, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Laboratory Accreditation frecord →
Dec 19, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Notification Procedures for Statements on Dierecord →
Dec 18, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advanced Manufacturing Tecrecord →
Dec 18, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitionsrecord →
Dec 18, 2024NoticeFiscal Year 2025 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Commentsrecord →
Dec 18, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; SOHONOSrecord →
Dec 18, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BYLVAYrecord →
Dec 12, 2024NoticeAdvisory Committee; Science Board to the Food and Drug Administration; Renewalrecord →
Dec 12, 2024NoticeRegistration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availabilityrecord →
Dec 12, 2024NoticeRevocation of Authorization of Emergency Use of B. Braun Medical's Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Irecord →
Dec 12, 2024Proposed RuleLeprino Nutrition; Filing of Food Additive Petitionrecord →
Dec 09, 2024NoticeStandardized Format for Electronic Submission of Marketing Application Content for the Planning of Bioresearch Monitoring Inspections for Cerecord →
Dec 09, 2024NoticeJoint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Nrecord →
Dec 06, 2024NoticeExpedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availabilityrecord →
Dec 05, 2024NoticeDetermination That Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, and Other Drug Products Were Nrecord →
Dec 05, 2024NoticeYong Sheng Jiao; Denial of Hearing; Final Debarment Orderrecord →
Dec 04, 2024NoticeFood Date Labelingrecord →
Dec 04, 2024NoticeNotifying the Food and Drug Administration of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infarecord →
Dec 04, 2024NoticeMarketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; record →
Dec 04, 2024NoticeEvaluating Target Animal Safety and Effectiveness of Antibacterial New Animal Drugs for Bovine Mastitis; Draft Guidance for Industry; Availarecord →
Dec 03, 2024NoticeFood and Drug Administration Report and Plan on Best Practices for Guidance; Availabilityrecord →
Dec 03, 2024NoticeFood and Drug Administration's Best Practices for Food and Drug Administration Communication With Interested Parties: Draft Report for Publirecord →
Dec 02, 2024RuleNew Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsorrecord →
Dec 02, 2024NoticeAdvancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities; Public Meeting; Request for Commentsrecord →
Dec 02, 2024NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; KEBILIDI (eladocagene exuparvovec-tneq)record →
Dec 02, 2024NoticeAnesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologirecord →
Nov 29, 2024NoticeUse of Circulating Tumor Deoxyribonucleic Acid for Curative-Intent Solid Tumor Drug Development; Guidance for Industry; Availabilityrecord →
Nov 29, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigatorsrecord →
Nov 29, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Applicationrecord →
Nov 29, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devicesrecord →
Nov 27, 2024NoticeRecommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healrecord →
Nov 27, 2024NoticeAdvisory Committee; Oncologic Drugs Advisory Committee; Renewalrecord →
Nov 27, 2024NoticeAssessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products; Draft Guidance for Industry; Availabirecord →
Nov 26, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Substantial Equivalence Rerecord →
Nov 26, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Tobacco Product record →
Nov 26, 2024NoticeTransitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices; Guidance for Industry and Food and record →
Nov 25, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the record →
Nov 22, 2024NoticeOrthopedic Non-Spinal Bone Plates, Screws, and Washers-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug record →
Nov 21, 2024Notice510(k) Third Party Review Program and Third Party Emergency Use Authorization Review; Guidance for Industry, Food and Drug Administration Strecord →
Nov 21, 2024NoticeDevelopment of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meerecord →
Nov 20, 2024NoticeStatement of Organization, Functions, and Delegations of Authorityrecord →
Nov 20, 2024NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availabilityrecord →
Nov 20, 2024NoticePer- and Polyfluoroalkyl Substances in Seafood; Request for Informationrecord →
Nov 20, 2024NoticeDetermination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectivenrecord →
Nov 20, 2024NoticeDetermination That IC-GREEN (Indocyanine Green), 25 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
Nov 20, 2024NoticeMiguel Angel Montalvo Villa: Final Debarment Orderrecord →
Nov 20, 2024NoticeRevocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availabilityrecord →
Nov 20, 2024NoticeDetermination That FORTESTA (Testosterone) Gel, 10 Milligrams/0.5 Gram Actuation, Was Not Withdrawn From Sale for Reasons of Safety or Effecrecord →
Nov 19, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; AGILI-Crecord →
Nov 19, 2024NoticeIvette Maria Portela Martinez: Final Debarment Orderrecord →
Nov 19, 2024NoticePfizer, Inc., et al.; Withdrawal of Approval of 26 New Drug Applicationsrecord →
Nov 19, 2024NoticeDetermination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrrecord →
Nov 19, 2024NoticeDetermination That HYDROCORTONE (Hydrocortisone Sodium Phosphate) Injection, Equivalent to 50 Milligrams Base/Milliliter, Was Not Withdrawn record →
Nov 19, 2024NoticeKevin Sheng Hsiang Fang: Final Debarment Orderrecord →
Nov 19, 2024NoticeFrequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Draft Guidance for Industry; Availabilityrecord →
Nov 18, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug User Fee Programrecord →
Nov 15, 2024NoticeNonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; Availabilityrecord →
Nov 14, 2024NoticePatient-Focused Drug Development: Workshop To Discuss Methodologic and Other Challenges Related to Patient Experience Data; Public Workshop;record →
Nov 13, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Produce Regulatory Programrecord →
Nov 13, 2024NoticePublic Workshop on Optimizing the Use of Real-World Evidence in Regulatory Decision-Making for Drugs and Biological Products-Looking Forwardrecord →
Nov 13, 2024NoticeDetermination That NUPLAZID (Pimavanserin Tartrate) Tablet, Equivalent 17 Milligram Base, Was Not Withdrawn From Sale for Reasons of Safety record →
Nov 08, 2024NoticeAmending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Urecord →
Nov 08, 2024RuleColor Additive Certification; Increase in Fees for Certification Servicesrecord →
Nov 08, 2024NoticeExport Lists for Human Food: Request for Informationrecord →
Nov 04, 2024NoticeSec. 540.525 Scombrotoxin (Histamine)-Forming Fish and Fishery Products-Decomposition and Histamine (CPG 7108.24) Compliance Policy Guide; Grecord →
Nov 04, 2024NoticeVoluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Forecord →
Nov 01, 2024NoticeReauthorization of the Over-The-Counter Monograph Drug User Fee Program; Public Meeting; Request for Commentsrecord →
Oct 31, 2024NoticeM13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Guidance for Industry; Availabilrecord →
Oct 31, 2024NoticeProduct-Specific Guidances; Revised Draft Guidances for Industry; Availabilityrecord →
Oct 30, 2024Proposed RuleEnvironmental Defense Fund, et al.; Response to Objections and Requests for a Public Hearingrecord →
Oct 30, 2024RuleIndirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sarecord →
Oct 28, 2024RuleNew Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Addressrecord →
Oct 25, 2024NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Oct 25, 2024NoticePharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nomirecord →
Oct 25, 2024NoticeInsanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Guidance for Industryrecord →
Oct 24, 2024NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Commentsrecord →
Oct 24, 2024RuleFood and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Guidancerecord →
Oct 24, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adherence Potential and Parecord →
Oct 24, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Sales and Distributionrecord →
Oct 24, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturingrecord →
Oct 22, 2024NoticeDrug Interaction Information in Human Prescription Drug and Biological Product Labeling-Content and Format; Draft Guidance for Industry; Avarecord →
Oct 22, 2024NoticeChemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Avrecord →
Oct 21, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; Vyndamaxrecord →
Oct 21, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; Vyndaqelrecord →
Oct 21, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; Pascal Precision Transcatheter Valve Repair Systemrecord →
Oct 21, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; Gore Tag Thoracic Branch Endoprosthesisrecord →
Oct 18, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; Wavewriter Alpha Spinal Cord Stimulator Systemrecord →
Oct 18, 2024NoticeThe Accreditation Scheme for Conformity Assessment Program: Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and FDrecord →
Oct 18, 2024NoticeRecommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Brecord →
Oct 18, 2024RuleRegulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correctionrecord →
Oct 18, 2024NoticeDetermination That TAVIST (Clemastine Fumarate) Tablet, 2.68 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
Oct 18, 2024NoticeReview of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions Under Generic Drug User Fee Amendments; Guidarecord →
Oct 18, 2024NoticeLinde, Inc.; Withdrawal of Approval of a New Drug Application and New Animal Drug Application for Helium, USPrecord →
Oct 18, 2024NoticePostoperative Nausea and Vomiting: Developing Drugs for Prevention; Draft Guidance for Industry; Availabilityrecord →
Oct 18, 2024NoticeConsiderations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Guidance for Industry; Availabilityrecord →
Oct 18, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; EXXUArecord →
Oct 18, 2024NoticeCore Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry; Availabilityrecord →
Oct 17, 2024NoticeTemporary Policies for Compounding Certain Parenteral Drug Products; Guidance for Industry; Availabilityrecord →
Oct 17, 2024NoticeRequests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments; Guidance for Industry; Availabilityrecord →
Oct 16, 2024NoticeDetermination That NOXAFIL (Posaconazole) Delayed-Release Tablets, 100 Grams Was Not Withdrawn From Sale for Reasons of Safety or Effectivenrecord →
Oct 15, 2024NoticeRevocation of Emergency Use of a Biological Product During the COVID-19 Pandemic; Availabilityrecord →
Oct 15, 2024NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; MIPLYFFA (Arimoclomol)record →
Oct 15, 2024NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; KISQALI (ribociclib)record →
Oct 15, 2024RuleMedical Devices; Quality System Regulation Amendments; Correctionrecord →
Oct 15, 2024NoticeUsing Relative Supersaturation To Support `Urinary Tract Health' Claims for Adult Maintenance Cat Food; Guidance for Industry; Availabilityrecord →
Oct 15, 2024NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; AQNEURSA (Levacetylleucine)record →
Oct 15, 2024NoticeEndosseous Dental Implants and Endosseous Dental Implant Abutments-Performance Criteria for Safety and Performance Based Pathway; Guidance frecord →
Oct 11, 2024NoticeNotice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2025 Proposed Guidance Developmentrecord →
Oct 11, 2024NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; TREMFYA (guselkumab)record →
Oct 02, 2024NoticeCellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemenrecord →
Oct 02, 2024NoticeElectronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry; record →
Oct 02, 2024NoticeEndocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Aprecord →
Oct 02, 2024NoticeDetermination That AUGMENTIN XR (Amoxicillin; Clavulanate Potassium) Extended-Release Tablets, 1 Gram; Equivalent to 62.5 Milligram Base, Warecord →
Oct 02, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Promotion of Prescription Drugs Within a Talk Show Formatrecord →
Oct 02, 2024NoticeCenter for Drug Evaluation and Research Quantitative Medicine Center of Excellence; Program Announcementrecord →
Oct 01, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic User Fee Paymenrecord →
Sep 30, 2024NoticeStatement of Organization, Functions, and Delegations of Authorityrecord →
Sep 30, 2024NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Sep 30, 2024NoticeRequest for Nominations for Individuals and Consumer Organizations for Advisory Committeesrecord →
Sep 30, 2024NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate record →
Sep 30, 2024NoticeAmended Environmental Assessment for Production of AquAdvantage Salmon at the Bay Fortune and Rollo Bay Facilities on Prince Edward Island, record →
Sep 30, 2024NoticeSafety and Performance Based Pathway Device-Specific Guidances; Guidance for Industry and Food and Drug Administration Staff; Availabilityrecord →
Sep 30, 2024NoticeClarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Guidance for Industry and Food and Drug Admirecord →
Sep 26, 2024Proposed RulePHM Brands; Withdrawal of Food Additive Petitionrecord →
Sep 26, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; OGSIVEOrecord →
Sep 25, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; OMLONTIrecord →
Sep 25, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; JESDUVROQrecord →
Sep 25, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authrecord →
Sep 25, 2024NoticeLive Biotherapeutic Products To Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants; Public Workshop; Request for Commentsrecord →
Sep 25, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ELUCIREMrecord →
Sep 25, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; FRUZAQLArecord →
Sep 25, 2024Proposed RuleMicrobiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devicesrecord →
Sep 25, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; DAYBUErecord →
Sep 25, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZAVZPRETrecord →
Sep 24, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; QUVIVIQrecord →
Sep 24, 2024RuleStandards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug record →
Sep 24, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; BRAVECTO; Correctionrecord →
Sep 24, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; OJJAARArecord →
Sep 23, 2024RuleMicrobiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Mrecord →
Sep 23, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Biosimilars User Fee Programrecord →
Sep 23, 2024NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Sep 23, 2024NoticeThe Accreditation Scheme for Conformity Assessment Program; Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and Forecord →
Sep 23, 2024NoticeChemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcementrecord →
Sep 23, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reportingrecord →
Sep 23, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Drug Compounding, Rerecord →
Sep 23, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; SYMDEKOrecord →
Sep 23, 2024NoticeAdvancing Smoking Cessation: Food and Drug Administration and National Institutes of Health Priorities; Public Meeting; Request for Commentsrecord →
Sep 23, 2024NoticeProgynon Associates, et al.; Withdrawal of Approval of Four New Drug Applicationsrecord →
Sep 23, 2024Proposed RuleDSM Biomedical; Filing of Color Additive Petitionrecord →
Sep 20, 2024RuleRegulatory Hearing Before the Food and Drug Administration; General Provisions; Amendmentsrecord →
Sep 20, 2024Proposed RuleRegulatory Hearing Before the Food and Drug Administration; General Provisions; Amendmentsrecord →
Sep 20, 2024Proposed RuleRevocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality Sysrecord →
Sep 20, 2024NoticeChemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Avrecord →
Sep 19, 2024NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments: Strarecord →
Sep 19, 2024NoticeAllergan, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applicationsrecord →
Sep 19, 2024NoticeFee Rate for Using a Priority Review Voucher in Fiscal Year 2025record →
Sep 19, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Corecord →
Sep 19, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Labeling Requirements for Prescription Drugsrecord →
Sep 18, 2024NoticeIntegrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice; Draft Guidance for Industry; Availrecord →
Sep 18, 2024NoticeConducting Clinical Trials With Decentralized Elements; Guidance for Industry, Investigators, and Other Interested Parties Availabilityrecord →
Sep 18, 2024NoticePharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nomirecord →
Sep 17, 2024NoticeChemistry, Manufacturing, and Controls Technical Section Filing Strategies; Draft Guidance for Industry; Availabilityrecord →
Sep 17, 2024NoticeConsiderations for Generating Clinical Evidence From Oncology Multiregional Clinical Development Programs; Draft Guidance for Industry; Avairecord →
Sep 17, 2024NoticeDigital Health Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Total Product Lifecycle Considerecord →
Sep 17, 2024RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Manarecord →
Sep 16, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ORSERDUrecord →
Sep 16, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; REZZAYOrecord →
Sep 16, 2024RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test Systemrecord →
Sep 16, 2024RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associatedrecord →
Sep 16, 2024NoticeElectronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Researrecord →
Sep 16, 2024RuleMedical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy Systemrecord →
Sep 13, 2024RuleEnforcement Policy for Required Warnings for Cigarette Packages and Advertisements; Guidance for Industry; Availabilityrecord →
Sep 13, 2024NoticeSandoz Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications; Correctionrecord →
Sep 13, 2024NoticeGeneral and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of Public Docket; Requrecord →
Sep 13, 2024NoticeNew Drugs Regulatory Program Modernization: Integrated Assessment of Marketing Applications and Integrated Review Documentation; Request forrecord →
Sep 12, 2024NoticeThe Food and Drug Administration's Draft Strategy Document on Innovative Manufacturing Technologiesrecord →
Sep 11, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZTALMYrecord →
Sep 11, 2024RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Devicerecord →
Sep 11, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VOQUEZNA DUAL PAK-New Drug Application 215153record →
Sep 11, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VOQUEZNA TRIPLE PAK-New Drug Application 215152record →
Sep 11, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TECHNEGASrecord →
Sep 11, 2024NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; OPZELURA (ruxolitinib)record →
Sep 09, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; PLUVICTOrecord →
Sep 09, 2024RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Devicerecord →
Sep 09, 2024RuleMedical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acirecord →
Sep 06, 2024NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Sep 06, 2024NoticeCardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Applicrecord →
Sep 06, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain record →
Sep 06, 2024NoticeIncorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administratiorecord →
Sep 06, 2024RuleMedical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profilerecord →
Sep 06, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; YCANTHrecord →
Sep 06, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; SEGLUROMETrecord →
Sep 06, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; STEGLATROrecord →
Sep 06, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; STEGLUJANrecord →
Sep 05, 2024RuleMedical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommenderrecord →
Sep 05, 2024RuleMedical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test Systemrecord →
Sep 05, 2024RuleFood Additives Permitted in Feed and Drinking Water of Animals; Pichia Pastoris Dried Yeastrecord →
Sep 05, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Crecord →
Sep 05, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Yale-Mayo Clinic Centers orecord →
Sep 05, 2024RuleMedical Devices; Dental Devices; Classification of the Radiofrequency Toothbrushrecord →
Sep 05, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information To Understand Challenges and Opportunirecord →
Sep 05, 2024RuleMedical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solutionrecord →
Sep 05, 2024NoticeControl of Nitrosamine Impurities in Human Drugs; Guidance for Industry; Availabilityrecord →
Sep 04, 2024NoticeDetermination That FLAGYL (Metronidazole) Tablets, 250 Milligrams and 500 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or record →
Sep 03, 2024NoticeIdentifying Priority Focus Areas for Future Guidance Development and Engagement With Interested Parties in Model-Informed Drug Development; record →
Sep 03, 2024RuleMedical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorderrecord →
Sep 03, 2024RuleMedical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compressionrecord →
Sep 03, 2024NoticeRevocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availabilityrecord →
Sep 03, 2024RuleMedical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Srecord →
Sep 03, 2024RuleMedical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Devicerecord →
Aug 30, 2024RuleProhibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Agerecord →
Aug 30, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence orecord →
Aug 29, 2024NoticeVoluntary Malfunction Summary Reporting Program for Manufacturers; Guidance for Industry and Food and Drug Administration Staff; Availabilitrecord →
Aug 29, 2024RuleMedical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturersrecord →
Aug 28, 2024NoticePatient Engagement Advisory Committee; Notice of Meeting-Patient-Centered Informed Consent in Clinical Studyrecord →
Aug 28, 2024NoticeDetermination That FENTANYL CITRATE Injections, Equivalent to 2.5 Milligram Base/50 Milliliter and Equivalent to 5 Milligram Base/100 Millilrecord →
Aug 28, 2024NoticeIssuance of Priority Review Voucher; Rare Pediatric Disease Product; LIVMARLI (maralixibat)record →
Aug 27, 2024NoticeAuthorization of Emergency Use of a Freeze-Dried Plasma Product for Treatment of Hemorrhage or Coagulopathy During an Emergency Involving Agrecord →
Aug 27, 2024NoticeDetermination That DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% (Diltiazem Hydrochloride), 125 Milligrams/125 Milliliters (1 Milligram/Milliliter)record →
Aug 26, 2024NoticeWithdrawal of Approval and Amending of Mammography Quality Standards Act Alternative Standardsrecord →
Aug 26, 2024RuleMammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administrecord →
Aug 23, 2024NoticeFinal Decision on the Proposal To Refuse To Approve a New Drug Application for ITCA 650record →
Aug 23, 2024NoticeOncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Immune Checkpoint Inhibitors irecord →
Aug 23, 2024NoticeAuthorization of Emergency Use of Certain Medical Devices During COVID-19; Availabilityrecord →
Aug 23, 2024NoticeElectronic Submission Template for Medical Device De Novo Requests; Guidance for Industry and Food and Drug Administration Staff; Availabilirecord →
Aug 23, 2024NoticeProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availabilityrecord →
Aug 22, 2024RuleFood Additives Permitted in Feed and Drinking Water of Animals; Fermented Ammoniated Condensed Wheyrecord →
Aug 22, 2024NoticePredetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availabilityrecord →
Aug 20, 2024NoticeDetermination That PENNSAID (Diclofenac Sodium) Topical Solution 2%, Was Not Withdrawn From Sale for Reasons of Safety or Effectivenessrecord →
Aug 20, 2024NoticeVaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Commentsrecord →
Aug 20, 2024NoticeProduct-Specific Guidance Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under the Generirecord →
Aug 16, 2024NoticeVoluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Forecord →
Aug 16, 2024RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Selected Microbial Agents That Caurecord →
Aug 16, 2024RuleMedical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARrecord →
Aug 16, 2024RuleMedical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Devicerecord →
Aug 16, 2024Proposed RuleSubmission of Food and Drug Administration Import Data in the Automated Commercial Environment for Certain Tobacco Productsrecord →
Aug 15, 2024NoticeScience Board to the Food and Drug Administration Advisory Committee; Notice of Meetingrecord →
Aug 15, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; MIEBOrecord →
Aug 15, 2024NoticeRyan Stabile: Final Debarment Orderrecord →
Aug 15, 2024NoticeCubist Pharmaceuticals LLC; Withdrawal of Approval of a New Drug Application for ENTEREG (Alvimopan) Capsules, 12 Milligramsrecord →
Aug 15, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Laboratory Accreditation for Analyses of Foodsrecord →
Aug 14, 2024NoticeInternational Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Hexahydrocannabinol; N-Pyrrolidinrecord →
Aug 13, 2024NoticeAdvisory Committee; Peripheral and Central Nervous System Drugs Advisory Committee; Renewalrecord →
Aug 12, 2024NoticeDevelopment of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meerecord →
Aug 12, 2024NoticeAgency Information Collection Activities; Proposed Collection; Risk/Safety Considerations and Motivations for Purchase and Use of Kratom andrecord →
Aug 12, 2024NoticeAdvancing Rare Disease Therapies Through a Food and Drug Administration Rare Disease Innovation Hub; Public Meeting; Request for Commentsrecord →
Aug 12, 2024NoticeGastrointestinal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental New Drug Arecord →
Aug 09, 2024NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approvalsrecord →
Aug 09, 2024NoticeBacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drug and Biological Products for Treatment; Revised Drafrecord →
Aug 09, 2024NoticeJoint Meeting of the Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs Advisory Committee; Notice of Meetrecord →
Aug 09, 2024NoticeOptimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases; Guidance for Industry; Avrecord →
Aug 09, 2024NoticeAnimal Food Ingredient Consultation; Draft Guidance for Industry; Availabilityrecord →
Aug 09, 2024NoticePre-Market Animal Food Ingredient Review Programs; Request for Commentsrecord →
Aug 09, 2024Proposed RuleFood and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Draft Gurecord →
Aug 08, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VANFLYTArecord →
Aug 08, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; REZLIDHIArecord →
Aug 08, 2024NoticeFlamingo Pharmaceuticals Ltd.; Proposal To Withdraw Approval of Two Abbreviated New Drug Applications; Opportunity for a Hearingrecord →
Aug 08, 2024NoticeAdvisory Committee; Blood Products Advisory Committee; Renewalrecord →
Aug 08, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; INPEFArecord →
Aug 08, 2024NoticeOffice of Pharmaceutical Quality Experiential Learning Site Visit Program; Program Announcementrecord →
Aug 08, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Cosmetic Export Crecord →
Aug 08, 2024NoticeAntimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 21397record →
Aug 08, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TALZENNArecord →
Aug 08, 2024NoticeAmending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Rrecord →
Aug 08, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Healthcare Provider Survey of Topics Related to Prescriptionrecord →
Aug 08, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; XOFLUZArecord →
Aug 08, 2024NoticeDetermination That DELATESTRYL (Testosterone Enanthate) Injection, 200 Milligrams/Milliliter, and Other Drug Products Were Not Withdrawn Frorecord →
Aug 08, 2024NoticeDetermination That CIPRO (Ciprofloxacin Hydrochloride) Tablet, Equivalent to 100 Milligrams Base, Was Withdrawn From Sale for Reasons of Safrecord →
Aug 07, 2024NoticeEnhancing Diversity in Therapeutics Development for Pediatric Patients; Public Workshoprecord →
Aug 05, 2024Proposed RuleGNT USA, LLC; Filing of Color Additive Petitionrecord →
Aug 05, 2024NoticeAdvisory Committee; Drug Safety and Risk Management Advisory Committee; Renewalrecord →
Aug 05, 2024NoticeAdvisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee; Renewalrecord →
Aug 02, 2024NoticeAdvisory Committee; Psychopharmacologic Drugs Advisory Committee; Renewalrecord →
Aug 02, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request: Risk/Safety Considerations and Motivations for Purchase and record →
Aug 02, 2024NoticeM12 Drug Interaction Studies; M12 Drug Interaction Studies: Questions and Answers; International Council for Harmonisation; Guidances for Inrecord →
Jul 31, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for Quantitative Testing for the Developmerecord →
Jul 31, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Class II Special Controls:record →
Jul 31, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; FDA Food Safety and Nutrition Surveyrecord →
Jul 31, 2024NoticePrescription Drug User Fee Rates for Fiscal Year 2025record →
Jul 31, 2024NoticeOutsourcing Facility Fee Rates for Fiscal Year 2025record →
Jul 31, 2024NoticeFood Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2025record →
Jul 31, 2024NoticeOver-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Request Fee Rates for Fiscal Year 2025record →
Jul 31, 2024NoticeFood Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2025record →
Jul 31, 2024NoticeMedical Device User Fee Rates for Fiscal Year 2025record →
Jul 31, 2024NoticeBiosimilar User Fee Rates for Fiscal Year 2025record →
Jul 31, 2024NoticeAnimal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2025record →
Jul 31, 2024NoticeFood Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2025record →
Jul 31, 2024NoticeAnimal Drug User Fee Rates and Payment Procedures for Fiscal Year 2025record →
Jul 31, 2024NoticeGeneric Drug User Fee Rates for Fiscal Year 2025record →
Jul 30, 2024NoticeAdvisory Committee; Pharmacy Compounding Advisory Committee; Renewalrecord →
Jul 29, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; National Agriculture and Frecord →
Jul 29, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Plant Varieties Intendrecord →
Jul 29, 2024NoticePediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Commentsrecord →
Jul 29, 2024NoticeFosun Pharma USA Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applicationsrecord →
Jul 29, 2024NoticeAdvisory Committee; Pulmonary-Allergy Drugs Advisory Committee; Renewalrecord →
Jul 25, 2024Proposed RuleFiling of Food Additive Petition From Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Food Safety, Environmental Wrecord →
Jul 25, 2024NoticeReal-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Precord →
Jul 25, 2024NoticeRevocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availabilityrecord →
Jul 25, 2024NoticeEvaluating the Immunogenicity Risk of Host Cell Proteins in Follow-On Recombinant Peptide Products; Establishment of a Public Docket; Requesrecord →
Jul 25, 2024NoticeAuthorization of Emergency Use of Certain Medical Devices During COVID-19; Availabilityrecord →
Jul 25, 2024NoticeProviding Over-the-Counter Monograph Submissions in Electronic Format; Guidance for Industry; Availabilityrecord →
Jul 25, 2024NoticeBiosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Commentsrecord →
Jul 25, 2024NoticeInternational Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Impurities: Residualrecord →
Jul 23, 2024NoticeFood and Drug Administration Information Technology Strategy and Customer Experience Strategy; Request for Comments; Extension of Comment Perecord →
Jul 23, 2024NoticeAgency Information Collection Activities; Announcement of Office of Management and Budget Approval; Survey on Quantitative Claims in Direct-record →
Jul 23, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Microbiological Testing and Corrective Measures for Bottled record →
Jul 23, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations Under the Federecord →
Jul 23, 2024NoticePostapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industryrecord →
Jul 22, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Diversity Action Plans for Clinical Studiesrecord →
Jul 22, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME; Correctionrecord →
Jul 22, 2024NoticeRecommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry; Availabilityrecord →
Jul 19, 2024NoticePediatric Inflammatory Bowel Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availabilityrecord →
Jul 18, 2024RuleBlood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availabilityrecord →
Jul 18, 2024NoticeClinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies; Guidance for Industry; Availabilityrecord →
Jul 18, 2024Proposed RulePhytolon Ltd.; Filing of Color Additive Petitionrecord →
Jul 17, 2024NoticeNotice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; VYVGART HYTRULO (efgartigimod alfa and hyaluronrecord →
Jul 17, 2024NoticePlatform Technology Designation Program; Draft Guidance for Industry; Extension of Comment Periodrecord →
Jul 16, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Substantial Equivalence Reports for Tobacco Productsrecord →
Jul 16, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Premarket Tobacco Product Applications and Recordkeeping Reqrecord →
Jul 15, 2024NoticeCellular and Gene Therapies Interactive Site Tours Program for Regulatory Project Managers and Reviewers; Information Available to Industryrecord →
Jul 15, 2024NoticeTakeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of New Drug Application for EXKIVITY (Mobocertinib Succinate) Capsule, Equivalenrecord →
Jul 12, 2024NoticeDental Composite Resin Devices and Dental Curing Lights-Premarket Notification (510(k)) Submissions Guidances; Draft Guidances for Industry record →
Jul 11, 2024NoticeClinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Guidance for Industry and Food and Drug Administrationrecord →
Jul 11, 2024NoticeReceipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar or Interchangeable Biosimilar Applicantrecord →
Jul 11, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; SPEVIGOrecord →
Jul 10, 2024NoticeWorkshop To Consider Artificial Intelligence in Drug and Biological Product Development; Public Workshoprecord →
Jul 10, 2024NoticeGenetic Metabolic Diseases Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Applicatiorecord →
Jul 10, 2024RuleAdvisory Committee; Allergenic Products Advisory Committee; Termination; Removal From List of Standing Committeesrecord →
Jul 09, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Reclassification Petitions for Medical Devicesrecord →
Jul 09, 2024NoticePurpose and Content of Use-Related Risk Analyses for Drugs, Biological Products and Combination Products; Draft Guidance for Industry and Forecord →
Jul 09, 2024NoticeRequest for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Corecord →
Jul 09, 2024NoticeAddressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers; Draft Guidance for Industry; Availability; Agrecord →
Jul 09, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Invesrecord →
Jul 05, 2024NoticeAuthorization of Emergency Use of Monkeypox Polymerase Chain Reaction Test Home Collection Kit in Response to an Outbreak of Mpox; Availabilrecord →
Jul 05, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; Imjudorecord →
Jul 05, 2024NoticeM14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment orecord →
Jul 05, 2024NoticeAuthorization of Emergency Use of an In Vitro Diagnostic Device in Response to an Outbreak of Mpox; Availabilityrecord →
Jul 05, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VABYSMOrecord →
Jul 05, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; RYSTIGGOrecord →
Jul 05, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; LUNSUMIOrecord →
Jul 05, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ENJAYMOrecord →
Jul 05, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; DAXXIFYrecord →
Jul 03, 2024RuleRevocation of Authorization for Use of Brominated Vegetable Oil in Foodrecord →
Jul 02, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; VYVGARTrecord →
Jul 02, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TECVAYLIrecord →
Jul 02, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ELFABRIOrecord →
Jul 02, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYMErecord →
Jul 02, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; KIMMTRAKrecord →
Jul 02, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; ZYNYZrecord →
Jul 02, 2024NoticeDetermination of Regulatory Review Period for Purposes of Patent Extension; TEZSPIRErecord →
Jul 01, 2024NoticeEssential Drug Delivery Outputs for Devices Intended To Deliver Drugs and Biological Products; Draft Guidance for Industry; Availabilityrecord →
Jun 28, 2024NoticeDiversity Action Plans To Improve Enrollment of Participants From Underrepresented Populations in Clinical Studies; Draft Guidance for Indusrecord →
Jun 28, 2024NoticeAgency Information Collection Activities; Proposed Collection; Comment Request; Produce Regulatory Program Standardsrecord →
Jun 26, 2024NoticePriority Zoonotic Animal Drug Designation and Review Process; Guidance for Industry; Availabilityrecord →
Jun 26, 2024NoticeEffectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs; Guidance forrecord →
Jun 26, 2024NoticeFood and Drug Administration Information Technology Strategy and Customer Experience Strategy; Request for Commentsrecord →
Jun 26, 2024NoticeAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Total Product Lirecord →
Jun 25, 2024NoticeLaboratory Developed Tests: Small Entity Compliance Guide; Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Avarecord →
Jun 24, 2024NoticeBest Practices for Meeting Management; Public Workshop; Request for Commentsrecord →
Jun 24, 2024NoticeFood and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 062record →
Jun 24, 2024NoticeChemistry, Manufacturing, and Controls in Support of Recombinant Protein Products for Veterinary Medicinal Use; Draft Guidance for Industry;record →
Jun 24, 2024NoticeChemistry, Manufacturing, and Controls Considerations for Type A Medicated Articles; Draft Guidance for Industry; Availabilityrecord →
Jun 24, 2024NoticeDetermination That INVEGA (Paliperidone) Extended-Release Tablet, 1.5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effecrecord →
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