FDA Regulatory Changes — 2023 archive
Every record published in 2023 — 426 in total. Follow any entry for the decoded detail page.
December 2023
- Electronic Submissions; Update to the Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports for Vaccines; Technical Specification
- Quality Considerations for Topical Ophthalmic Drug Products; Revised Draft Guidance for Industry; Availability
- Potency Assurance for Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability
- Reformulating Drug Products That Contain Carbomers Manufactured With Benzene; Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; CYTALUX
- Determination of Regulatory Review Period for Purposes of Patent Extension; PONVORY
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZOKINVY
- Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use); Chromium Propionate; Correction
- Determination of Regulatory Review Period for Purposes of Patent Extension; SCEMBLIX
- Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
- Rare Diseases: Considerations for the Development of Drugs and Biological Products; Guidance for Industry; Availability
- Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; Emgality
- Determination of Regulatory Review Period for Purposes of Patent Extension; Copiktra
- Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Guidance for Industry, Investigators, and Other Stakeholders; Availability
- Special Considerations, Incentives, and Programs To Support the Approval of New Animal Drugs for Minor Uses and for Minor Species; Guidance for Industry; Availability
- Real-World Data: Assessing Registries To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Data Standards for Drug and Biological Product Submissions Containing Real-World Data; Guidance for Industry; Availability
- Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
- Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization; Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Implied Claims in Direct-to-Consumer Prescription Drug Promotion
- Determination of Regulatory Review Period for Purposes of Patent Extension; LYBALVI
- 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability
- Notice to Public of Website Location of the Office of the Chief Scientist Proposed Guidance Development List
- Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability
- Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
- James Funaro: Final Debarment Order
- Jeremy Walenty: Final Debarment Order
- Food Additives Permitted in Feed and Drinking Water of Animals; Calcium Formate
- Determination That MEPHYTON (Phytonadione) Tablets, 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Apothecon, et al.; Withdrawal of Approval of 103 New Drug Applications and 35 Abbreviated New Drug Applications; Correction
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
- Priority Zoonotic Animal Drug Designation and Review Process; Draft Guidance for Industry; Availability
- Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications
- Pharmacyclics LLC.; Withdrawal of Approval of Indications for Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA (ibrutinib) Capsules and Tablets
- Adam Michael Nagy: Final Debarment Order
- Menu Labeling: Supplemental Guidance for Industry (Edition 2); Draft Guidance for Industry; Availability
- Revocation of Uses of Partially Hydrogenated Oils in Foods; Confirmation of Effective Date
- Request for Nominations for Voting Members for the Genetic Metabolic Diseases Advisory Committee
- Request for Nominations of Individuals and Consumer Organizations for the Genetic Metabolic Diseases Advisory Committee
- Request for Nominations of Individuals and Industry Organizations for the Genetic Metabolic Diseases Advisory Committee
- Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment
- Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
- Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Data Standards; Support and Requirement Begins for the Clinical Data Interchange Standards Consortium Version 2.0 of the Study Data Tabulation Model, Version 3.4 of the Study Data Tabulation Model Implementation Guide, and Version 1.0 of the Standard for Exchange of Nonclinical Data Implementation Guide-Genetox; Requirement Ends for the Clinical Data Interchange Standards Version 3.2 of the Study Data Tabulation Model Implementation Guide
- Methodological Challenges Related to Patient Experience Data; Summary of Received Comments
- Determination of Regulatory Review Period for Purposes of Patent Extension; WELIREG
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZYNLONTA
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Time and Extent Applications for Nonprescription Drug Products
- Determination of Regulatory Review Period for Purposes of Patent Extension; Nextstellis
- Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Tablets (New Drug Application 209816)
- Determination of Regulatory Review Period for Purposes of Patent Extension; Tivdak
- Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications; Correction
- Determination of Regulatory Review Period for Purposes of Patent Extension; Pemazyre
- Determination of Regulatory Review Period for Purposes of Patent Extension; Fotivda
- Determination of Regulatory Review Period for Purposes of Patent Extension; SEYSARA
- Determination of Regulatory Review Period for Purposes of Patent Extension; EXKIVITY
- Determination of Regulatory Review Period for Purposes of Patent Extension; VIZIMPRO
- Determination of Regulatory Review Period for Purposes of Patent Extension; VILTEPSO
- Bayer HealthCare Pharmaceuticals Inc., et al.; Withdrawal of Approval of CIPRO (Ciprofloxacin Hydrochloride) Oral Tablet, Equivalent to 100 Milligrams Base, and Five Generic Ciprofloxacin Hydrochloride, Oral Tablet, Equivalent to 100 Milligrams Base Drug Products
- Agency Information Collection Activities; Proposed Collection; Comment Request; Food Allergen Labeling and Reporting
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
- Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs; Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; Truseltiq
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability.
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
- Statement of Organization, Functions, and Delegations of Authority
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Device Tracking
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees
- Modified Risk Tobacco Product Application: Renewal Applications for General Snus Smokeless Tobacco Products Submitted by Swedish Match U.S.A., Inc.
November 2023
- Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials
- Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes
- Determination of Regulatory Review Period for Purposes of Patent Extension; ZEGALOGUE
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Product Jurisdiction and Combination Products
- Determination of Regulatory Review Period for Purposes of Patent Extension; Amondys 45
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications
- Determination of Regulatory Review Period for Purposes of Patent Extension; Qelbree
- Determination of Regulatory Review Period for Purposes of Patent Extension; Ukoniq
- Using Relative Supersaturation To Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food; Draft Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; Koselugo
- Determination of Regulatory Review Period for Purposes of Patent Extension; Rezurock
- Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Injection (New Drug Application 209817)
- Determination of Regulatory Review Period for Purposes of Patent Extension; Azstarys
- Determination of Regulatory Review Period for Purposes of Patent Extension; Lupkynis
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; State Petitions for Exemption From Preemption
- Determination of Regulatory Review Period for Purposes of Patent Extension; Kerendia
- Determination of Regulatory Review Period for Purposes of Patent Extension; Olinvyk
- Determination of Regulatory Review Period for Purposes of Patent Extension; Empaveli
- Determination of Regulatory Review Period for Purposes of Patent Extension; Tukysa
- Determination of Regulatory Review Period for Purposes of Patent Extension; ORGOVYX
- Determination of Regulatory Review Period for Purposes of Patent Extension; PYLARIFY
- Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt; Small Entity Compliance Guide; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; Zeposia
- Determination of Regulatory Review Period for Purposes of Patent Extension; Cosela
- Determination of Regulatory Review Period for Purposes of Patent Extension; Tavneos
- Determination of Regulatory Review Period for Purposes of Patent Extension; Korsuva
- Agency Information Collection Activities; Proposed Collection; Comment Request; Shortages Data Collections
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Qualitative Feedback on Agency Service Delivery
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability
- Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Extension of the Comment Period
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Extension of Comment Period
- Advancing Drug Development for the Prevention of Spontaneous Preterm Birth; Public Meeting
- Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice; Public Workshop; Request for Comments
- Determination That BUPRENEX (Buprenorphine Hydrochloride) Injection, 0.3 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Translation of Good Laboratory Practice Study Reports: Questions and Answers; Draft Guidance for Industry; Availability
- Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format
- Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement
- Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comments
- Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee
- Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Final Guidance for Industry and Food and Drug Administration Staff; and Select Updates for the 506J Guidance: 506J Device List and Additional Notifications; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-506J Device List
- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pulse Oximeters
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK INJECTION; Correction
- Advisory Committee; Nonprescription Drugs Advisory Committee; Renewal
- Determination That COGENTIN (Benztropine Mesylate) Injection, 1 Milligram per 1 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Multi-Cancer Detection Devices
- Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions
- Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing; Guidance for Industry; Availability
- Real-Time Oncology Review; Guidance for Industry; Availability
- Phibro Animal Health Corp.; Proposal To Withdraw Approval of New Animal Drug Applications for Carbadox in Medicated Swine Feed; Opportunity for a Hearing
- Phibro Animal Health Corp.; Carbadox in Medicated Swine Feed; Revocation of Approved Method
- Determination That FORADIL (Formoterol Fumarate) Inhalation Powder, 0.012 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Revocation of Authorization for Use of Brominated Vegetable Oil in Food
- Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers; Request for Comments
- Enforcement Policy for Clinical Electronic Thermometers; Guidance for Industry and Food and Drug Administration Staff; Availability
- Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue
- Advisory Committee; Patient Engagement Advisory Committee; Renewal
- Enforcement Policy for Certain Supplements for Approved Premarket Approval or Humanitarian Device Exemption Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
- David Winne: Grant of Special Termination; Final Order Terminating Debarment
- Determination That CALCIUM DISODIUM VERSENATE (Edetate Calcium Disodium) Injection, 200 Milligrams per Milliliter, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
- Determination of Regulatory Review Period for Purposes of Patent Extension; Omegaven
October 2023
- Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Standardized Reporting Forms for Food and Drug Administration Federally Funded Public Health Projects and Agreements
- Agency Information Collection Activities; Proposed Collection; Comment Request; Export Certificates for Food and Drug Administration Regulated Products
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Revised Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
- Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2024
- Animal Generic Drug User Fee Program Rates and Payment Procedures for Fiscal Year 2024
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
- Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Guidance for Industry; Availability
- Benefit-Risk Assessment for New Drug and Biological Products; Guidance for Industry; Availability
- Development and Licensure of Vaccines To Prevent COVID-19; Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups and Interviews as Used by the Food and Drug Administration
- American Regent, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
- Food and Drug Administration; Center of Drug Evaluation and Research Guidance Documents Related to Coronavirus Disease 2019, Expiration
- Enforcement Policy for Non-Invasive Remote Monitoring Devices Used To Support Patient Monitoring; Guidance for Industry and Food and Drug Administration Staff; Availability
- Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry; Availability
- Determination That NAROPIN (Ropivacaine Hydrochloride) Solution, 50 Milligrams/10 Milliliters and 75 Milligrams/10 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Agency Information Collection Activities; Proposed Collection; Comment Request; Improving the Quality and Representativeness of the Treatment Center Program Data-Data Modifications to the Current Survey Instrument Format to Minimize Misclassification
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification
- Guidance Documents Referencing Pre-Existing Tobacco Products; Guidance for Industry; Availability; Withdrawal
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Diabetic Foot Infections: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol; Guidance for Industry; Availability
- Determination That ZOFRAN ODT (Ondansetron) Orally Disintegrating Tablets, 4 Milligrams and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Kerry Ingredients and Flavours Ltd.; Filing of Food Additive Petition
- Kerry Inc.; Filing of Food Additive Petition
- Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry; Availability
- Quality Considerations for Topical Ophthalmic Drug Products; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Importation of Prescription Drugs
- Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
- Determination That MEKINIST (Trametinib Dimethyl Sulfoxide) Tablets, 1 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Determination That CYTOXAN (Cyclophosphamide) for Injection (Sterile Dry Powder Excipient-Free Formulation), 500 Milligrams/Vial, 1 Gram/Vial, and 2 Grams/Vial, and CYTOXAN (Cyclophosphamide) for Injection (Sterile Dry Powder With Sodium Chloride Formulation), 500 Milligrams/Vial, 1 Gram/Vial, and 2 Grams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Agency Information Collection Activities; Proposed Collection; Comment Request; Cattle Materials Prohibited From Use in Animal Food or Feed
- Advisory Committee; Digital Health Committee; Establishment
- Request for Nominations of Individuals and Consumer Organizations for the Digital Health Advisory Committee
- Request for Nominations of Individuals and Industry Organizations for the Digital Health Advisory Committee
- Request for Nominations for Voting Members for the Digital Health Advisory Committee
- Agency Information Collection Activities; Proposed Collection; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Food and Drug Administration Information Technology Strategy; Request for Comments; Correction
- Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of Mpox; Availability
- Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
- Revocation of Eleven Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
- Stimulant Use Disorders: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- User Fee Rates for Fiscal Year 2024; Change of Address
- Determination That ULTRAM (Tramadol Hydrochloride) Tablets, 50 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Dr. Reddy's Laboratories, Inc.; Withdrawal of Approval of 11 Abbreviated New Drug Applications
- Revocation of Authorization of Emergency Use of Becton, Dickinson and Company Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site); Availability
- Medical Devices; Laboratory Developed Tests
- Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program; Program Announcement
- Human Prescription Drug and Biological Products-Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers-“Dose Banding”; Guidance for Industry; Availability
September 2023
- Draft Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption; and Guidance for Industry: Standards for the Growing, Harvesting, Packing, and Holding of Sprouts for Human Consumption; Availability
- Electronic Submission Template for Medical Device De Novo Requests; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Antimicrobial Susceptibility Test System Devices-Updating Breakpoints in Device Labeling; Guidance for Industry; Availability
- Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Guidance for Industry and Food and Drug Administration Staff; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recalls
- Fee Rate for Using a Priority Review Voucher in Fiscal Year 2024
- Graft-Versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment; Draft Guidance for Industry; Availability
- Agency Information Collection Activities: Proposed Collection; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
- Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Food and Drug Administration Approval To Market a New Drug
- Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
- Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments; Reopening of the Comment Period
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- Requirements for Additional Traceability Records for Certain Foods; Technical Amendment
- Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients With Renal Impairment; Public Workshop
- Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Draft Guidance for Industry; Availability
- Yogurt Products Deviating From Standard of Identity; Amendment of Temporary Marketing Permit
- Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications; Correction
- In-Home Disposal Systems for Opioid Analgesics; Request for Information; Reopening of the Comment Period
- Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry; Availability
- Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503
- Scientific Challenges and Opportunities To Advance the Development of Individualized Cellular and Gene Therapies; Request for Information
- Menopause: Potential Impact on Clinical Pharmacology and Opportunities for Future Research; Public Workshop
- Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies; Guidance for Industry, Investigators, and Institutional Review Boards; Availability
- Advisory Committee; Board of Tea Experts; Termination and Technical Amendment to the Citation for the Federal Advisory Committee Act
- Food and Drug Administration Information Technology Strategy; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary National Retail Food Regulatory Program Standards
- Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs
- Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Records; Electronic Signatures
- Regulatory Considerations for Prescription Drug Use-Related Software; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Facility Registration, Product Listing, and Labeling Requirements
- Labeling for Biosimilar and Interchangeable Biosimilar Products; Draft Guidance for Industry; Availability
- Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals; Draft Guidance for Industry; Availability
- Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff; Availability
- Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989; Guidance for Industry; Availability
- Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments
- Fostering Medical Device Improvement: Food and Drug Administration Activities and Engagement With the Voluntary Improvement Program; Guidance for Industry and Food and Drug Administration Staff; Availability
- Medical Devices With Indications Associated With Weight Loss Guidances; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
- Determination That Oxandrin (Oxandrolone) Tablets, 2.5 Milligrams and 10 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness
- Over-the-Counter Monograph Drug User Fee Program-OTC Monograph Order Requests Fee Rates for Fiscal Year 2024
- Mayya Tatsene: Final Debarment Order
- Clinical Pharmacology Considerations for Peptide Drug Products; Draft Guidance for Industry; Availability
- Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on the Vaccines and Related Biological Products Advisory Committee
- Request for Nominations of a Nonvoting Representative of the Interest of the Tobacco Manufacturing Industry on the Tobacco Products Scientific Advisory Committee
- Institutional Review Board Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products; Guidance for Institutional Review Boards and Clinical Investigators; Availability
- Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement
- Use of International Standard ISO 10993-1, “Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process”; Guidance for Industry and Food and Drug Administration Staff; Availability
- Application of Human Factors Engineering Principles for Combination Products: Questions and Answers; Guidance for Industry and FDA Staff; Availability
- Endpoints and Trial Designs To Advance Drug Development in Kidney Transplantation; Public Meeting
- Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Endogenous Cushing's Syndrome: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
- Modernizing the Food and Drug Administration's Premarket Notification Program; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
- Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Sickle Cell Disease
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product
- Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container
- Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs; Guidance for Industry; Availability
- Merck Sharp & Dohme LLC, et al.; Withdrawal of Approval of 35 New Drug Applications
- Reauthorization of the Over-the-Counter Monograph Drug User Fee Program; Public Meeting; Request for Comments
- Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium Avium Complex: Developing Drugs for Treatment; Guidance for Industry; Availability
- Post-Warning Letter Meetings Under the Generic Drug User Fee Act; Draft Guidance for Industry; Availability
- Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product-Compliance Policies, Revision 1; Guidance for Industry; Availability
August 2023
- Agency Information Collection Activities; Proposed Collection; Comment Request; Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by the Center for Veterinary Medicine
- Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act; Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Rapid Response Surveys
- Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
- Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Customer/Partner Service Satisfaction Surveys
- Proposed Requirements for Tobacco Product Manufacturing Practice; Extension of Comment Period
- Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act-Compliance Policies; Guidance for Industry; Availability
- Fish and Shellfish; Canned Tuna Standard of Identity and Standard of Fill of Container
- Notice of Opportunity for Public Comment on Proposal To Withdraw Approval of New Drug Application for PEPAXTO, Equivalent to 20 Milligrams Base per Vial
- Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; Extension of the Comment Period
- Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Alternative Form of Hearing
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice for Blood and Blood Components and Reducing the Risk of Transfusion-Transmitted Infections
- Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Workshop To Enhance Clinical Study Diversity; Public Workshop; Request for Comments
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
- List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- Statement of Organization, Functions, and Delegations of Authority
- Determination That BORTEZOMIB (Bortezomib) Solution, 2.5 Milligrams/Milliliter and 3.5 Milligrams/1.4 Milliliter (2.5 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- David Winne; Denial of Hearing; Final Debarment Order
- Optimizing the Use of Postapproval Pregnancy Safety Studies; Public Workshop; Request for Comments
- Food Standards of Identity Modernization; Pasteurized Orange Juice; Request for Information
- New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
- Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability; Reopening of the Comment Period
- Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologics License Applications Procedures and Requirements; Voluntary Consensus Standards
- Ildiko M. Knoll: Final Debarment Order
- Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Statement of Organization, Functions, and Delegations of Authority
- Determination of Regulatory Review Period for Purposes of Patent Extension; Vercise Genus Deep Brain Stimulation System
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Animal Drug and Animal Generic Drug User Fee Submissions
- Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry; Availability
- Classification Categories for Certain Supplements Under the Biosimilar User Fee Amendments of 2022; Draft Guidance for Industry; Availability
- Determination That ANJESO (Meloxicam) Solution, 30 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals
- Postmarketing Approaches To Obtain Data on Under-Represented Populations in Clinical Trials; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing Material From Cattle
- Development of Small Dispensers Assessment Under the Drug Supply Chain Security Act; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling Requirements
- Request for Nominations on the Tobacco Products Scientific Advisory Committee-Small Business Pool
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Voluntary Qualified Importer Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
- Agency Information Collection Activities; Proposed Collection; Comment Request; Color Additive Certification
- Revocation of Uses of Partially Hydrogenated Oils in Foods; Companion Document to Direct Final Rule
- Revocation of Uses of Partially Hydrogenated Oils in Foods
- Registration and Listing of Cosmetic Product Facilities and Products; Draft Guidance for Industry; Availability
- Pilot Program for Cosmetic Product Facility Registration and Listing Electronic Submissions User Acceptance Testing
- Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational New Drug Application Requirements
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
- QTc Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device Tracking
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 060
- Determination That CUBICIN (Daptomycin) Powder for Injection, 250 Milligrams/Vial and 500 Milligrams/Vial, and CUBICIN RF (Daptomycin) Powder for Injection, 500 Milligrams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Bromazolam; Flubromazepam; Butonitazene; 3-Chloromethcathinone (3-CMC); Dipentylone; 2-Fluorodeschloroketamine (2-FDCK); Nitrous Oxide (N2O); Carisoprodol; Request for Comments
- Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities; Guidance for Industry; Availability
- Determination of Regulatory Review Period for Purposes of Patent Extension; DELSTRIGO-New Drug Application 210807
- Determination of Regulatory Review Period for Purposes of Patent Extension; PIFELTRO-New Drug Application 210806
- Determination of Regulatory Review Period for Purposes of Patent Extension; VERCISE DEEP BRAIN STIMULATION SYSTEM
- Determination of Regulatory Review Period for Purposes of Patent Extension; BARRICAID ANULAR CLOSURE DEVICE
- Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry; Availability
- Determination That K-TAB (Potassium Chloride) Extended-Release Tablets, 10 Milliequivalents and 20 Milliequivalents, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies; Public Meeting
- Raidel Figueroa: Final Debarment Order
- Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability
- Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals Under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
- Prescription Drug User Fee Rates for Fiscal Year 2024; Correction
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 059
- Agency Information Collection Activities; Proposed Collection; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations
- Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification for a New Dietary Ingredient
- Determination That Progesterone Injection, USP, 50 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
July 2023
- Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products
- Agency Information Collection Activities; Proposed Collection; Comment Request; State Petitions for Exemption From Preemption
- Outsourcing Facility Fee Rates for Fiscal Year 2024
- Prescription Drug User Fee Rates for Fiscal Year 2024
- Biosimilar User Fee Rates for Fiscal Year 2024
- Medical Device User Fee Rates for Fiscal Year 2024
- Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2024
- Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2024
- Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2024
- Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices-Voluntary Improvement Program
- Generic Drug User Fee Rates for Fiscal Year 2024
- Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
- Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
- Center for Drug Evaluation and Research's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality; Guidance for Industry; Availability
- Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Diana Daffin: Final Debarment Order
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on Front of Package Labeling on Packaged Foods; Reopening of the Comment Period
- M7(R2) Assessment and Control of Deoxyribonucleic Acid Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk, M7(R2) Addendum, and M7(R2) Questions and Answers; International Council for Harmonisation; Guidances for Industry; Availability
- Public Meeting and Listening Session for Developing the Food and Drug Administration's Center for Tobacco Products' Strategic Plan; Request for Comments
- Bristol Myers Products Inc.; Withdrawal of Approval of a New Drug Application for BUFFERIN (Aspirin) Tablets
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice for Blood and Blood Components and Reducing the Risk of Transfusion-Transmitted Infections
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Potential Tobacco Product Violations Reporting Form
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
- Agency Information Collection Activities; Proposed Collection; Comment Request; Temporary Marketing Permit Applications
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product
- Nomenclature Change for Dockets Management; Technical Amendment
- Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance With Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
- Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; Availability
- Advisory Committee; National Mammography Quality Assurance Advisory Committee; Renewal
- Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative
- Request for Nominations From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees
- Pediatric Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Mark Moffett; Conviction Reversal; Final Order Withdrawing Debarment Order
- Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
- Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development; Draft Guidance for Industry; Availability
- Nonprescription Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Use Authorization of Medical Products and Related Authorities
- Medical Imaging Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Human Cells, Tissues, and Cellular and Tissue-Based Products
- Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
June 2023
- Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment; Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary National Retail Food Regulatory Program Standards
- Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Accreditation Scheme for Conformity Assessment Program
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Advisory Committee Regulations
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Imports and Electronic Import Entries
- Patient-Matched Guides to Orthopedic Implants; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Gemini Laboratories, LLC, et al.; Withdrawal of Approval of One New Drug Application for OXANDRIN (Oxandrolone) Tablets and Four Abbreviated New Drug Applications for Oxandrolone Tablets
- Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
- Filing of Color Additive Petition From Environmental Defense Fund, et al.; Request To Revoke Color Additive Listing for Use of Titanium Dioxide in Food; Extension of Comment Period
- Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements; Guidance for Industry; Availability
- Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
- Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability
- Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding When Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry; Availability
- Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal
- Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
- PHM Brands; Filing of Food Additive Petition
- Oncology Drug Products Used With Certain In Vitro Diagnostic Tests: Pilot Program; Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff; Availability
- Daylen Diaz: Final Debarment Order
- Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
- Questions and Answers About Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry; Extension of the Comment Period
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Quantitative Research on Front of Package Labeling on Packaged Foods
- Content of Premarket Submissions for Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability
- Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination; Draft Guidance for Industry; Availability
- Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)
- Luis Anarbol Moran: Final Debarment Order
- Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification of Devices
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Practices and Procedures
- Advisory Committee; Dermatologic and Ophthalmic Drugs Advisory Committee; Renewal
- Clinical Drug Interaction Studies With Combined Oral Contraceptives; Guidance for Industry; Availability
- Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry; Availability
- Determination That BUSPAR (Buspirone Hydrochloride) Capsules, 5 Milligrams, 7.5 Milligrams, 10 Milligrams, and 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
- Analay Rico: Final Debarment Order
- Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs
- Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal
- E6(R3) Guideline for Good Clinical Practice; International Council for Harmonisation; Draft Guidance for Industry; Availability
- Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability
- Issuance of Priority Review Voucher; Rare Pediatric Disease Product
- Cover Letter Attachments for Controlled Correspondence and Abbreviated New Drug Application Submissions; Guidance for Industry; Availability
- Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications; Correction
- Vintage Pharmaceuticals; Withdrawal of Approval of Abbreviated New Drug Application for Pemoline Tablets, 18.75 Milligrams, 37.5 Milligrams, and 75 Milligrams
- Authorization of Emergency Use of a Drug Product During the COVID-19 Pandemic; Availability
- Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals; Guidance for Industry; Availability
- Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment; Revised Draft Guidance for Industry; Availability
- Drug-Drug Interaction Assessment for Therapeutic Proteins; Guidance for Industry; Availability
Data: the U.S. Federal Register (Food and Drug Administration documents). Industry tags are a SPEQ keyword-derived interpretation, not official Federal Register metadata. Follow any entry for the authoritative document.