Documents

Federal rules and notices from the public comment record, analyzed continuously.

• Citizen Petition from Lauren H. Schwartz, et al.FDAOther
  6,999 comments · 95 awaiting analysis
• Citizen Petition from Children’s Health DefenseFDAOther
  4,827 comments · 68 awaiting analysis
• The "Deemed To Be a License" Provision of the BPCI Act; Questions and Answers; Guidance for IndustryFDAOther
  4,223 comments
• Citizen Petition from American Pastured Poultry Producers AssociationFDAOther
  1,616 comments · 5 awaiting analysis
• List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic ActFDANoticeCloses Jul 1, 2026
  624 comments · 22 awaiting analysis
• Drug Repurposing for Unmet Medical Needs; Request for InformationFDANoticeCloses Jun 12, 2026
  455 comments · 40 awaiting analysis
• Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for CommentsFDANoticeCloses Jun 30, 2026
  203 comments · 4 awaiting analysis
• AI-Enabled Optimization of Early- Phase Clinical Trials Pilot Program; Request for InformationFDANoticeCloses Jun 30, 2026
  121 comments · 1 awaiting analysis
• Citizen Petition from Johanna IhliFDAOther
  89 comments · 4 awaiting analysis
• ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a HearingFDANoticeCloses Jun 30, 2026
  67 comments · 5 awaiting analysis
• Citizen Petition from Consumers for Dental Choice, et al.FDAOther
  53 comments
• Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and CommentsFDANoticeCloses Jul 1, 2026
  16 comments
• Guidance for Industry; Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionFDAOther
  10 comments · 1 awaiting analysis
• Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for CommentsFDANoticeCloses Jul 1, 2026
  7 comments
• Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations; Guidance for Industry and Food and Drug Administration Staff - Final GuidanceFDAOther
  6 comments · 4 awaiting analysis
• Citizen Petition from Pharmaceutical Safety Oversight CouncilFDAOther
  6 comments · 2 awaiting analysis
• Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices; Guidance for Investigators, Industry, and Institutional Review Boards - Final GuidanceFDAOther
  4 comments · 3 awaiting analysis
• Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.FDANoticeCloses Jun 18, 2026
  4 comments
• Animal Drug User Fee Act; Public Meeting; Request for CommentsFDANoticeCloses Dec 2, 2027
  3 comments · 2 awaiting analysis
• General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration StaffFDAOther
  3 comments · 3 awaiting analysis
• Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for CommentsFDANoticeCloses Jul 16, 2026
  2 comments · 1 awaiting analysis
• Electronic Submission of Postmarketing Individual Case Safety Reports to the Food and Drug Administration Adverse Event Monitoring System Using International Council of Harmonisation E2B(R3) Data Standards; Regional Data Elements and Implementation ScheduleFDANoticeCloses Oct 2, 2026
  2 comments · 1 awaiting analysis
• Clinical Decision Support Software Guidance for Industry and Food and Drug Administration StaffFDAOther
  2 comments · 2 awaiting analysis
• Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products; Guidance for IndustryFDAOther
  2 comments
• Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration StaffFDAOtherCloses Jun 23, 2026
  2 comments
• PSG_020076 - Draft Guidance on NicotineFDAOtherCloses Apr 29, 2026
  1 comment
• Questions and Answers on Biosimilar Development and the BPCI Act - Guidance for IndustryFDAOther
  1 comment · 1 awaiting analysis
• Electronic Method for Specific Electronic Submissions to FDA's Dockets Management StaffFDAOther
  1 comment · 1 awaiting analysis
• Computer Software Assurance for Production and Quality Management System Software Guidance for Industry and Food and Drug Administration StaffFDAOther
  1 comment · 1 awaiting analysis
• Food Additive Petition seeking amended food additive regulations to remove FDA's approval of four carcinogenic solventsFDAOtherCloses Jun 30, 2026
  1 comment
• Certain Estrogen-Androgen Combination Drugs; Drugs for Human Use; Drug Efficacy Study Implementation; Amendment and Opportunity for HearingFDANotice
  0 comments
• Drug and Device Manufacturer Communications With Payors Formulary Committees and Similar Entities - Questions and Answers - Guidance for Industry and Review StaffFDAOther
  0 comments
• Interim ResponseFDAOther
  0 comments
• ComplaintFDAOther
  0 comments
• ComplaintFDAOther
  0 comments
• ComplaintFDAOther
  0 comments
• ComplaintFDAOther
  0 comments
• ComplaintFDAOther
  0 comments
• ComplaintFDAOther
  0 comments
• ComplaintFDAOther
  0 comments
• ComplaintFDAOther
  0 comments
• Citizen Petition from HQ Pharma (Shanghai) Co., Ltd.FDAOther
  0 comments
• Response Letter from FDA CDER to HQ Pharma (Shanghai) Co., Ltd.FDAOther
  0 comments
• Citizen Petition from Animal Defenders InternationalFDAOther
  0 comments
• Acknowledgement Letter from FDA DMB to Animal Defenders InternationalFDAOther
  0 comments
• Citizen Petition from Evan H. CoutureFDAOther
  0 comments
• Acknowledgement Letter from FDA DMB to Evan H. CoutureFDAOther
  0 comments
• Citizen Petition from Windels Marx Lane & Mittendorf, LLPFDAOther
  0 comments
• Acknowledgement Letter from FDA DMB to Windels Marx Lane & Mittendorf, LLPFDAOther
  0 comments
• Reference 1 - Draft Guidance on Dabrafenib MesylateFDASupporting & Related Material
  0 comments