Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009
Requests that the Food and Drug Administration issue a written determination regarding the regulatory status of fluoride compounds distributed for community water fluoridation
1 awaiting analysis
Requests that the FDA Open a Docket, Hold a Part 15 Public Hearing Regarding the Off-Label Use of Estrogen in Natal Males for Gender Affirmation, and Consider Regulatory Action Including a Boxed Warning Under 21 C.F.R. § 201.80(e)
20 awaiting analysis
Request that the FDA, acting through its Center for Veterinary Medicine ("CVM"), exercise its post-approval oversight authority to impose enforceable safe-use conditions for Librela (bedinvetmab injection) (NADA 141-562), a caninized monoclonal antibody approved for the control of pain associated with osteoarthritis in dogs
7 awaiting analysis
Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development; Draft Guidance for Industry; Availability
Request that the FDA remove the Mifepristone REMS Program, including but not limited to the Prescriber Certification, Pharmacy Certification, and Patient Agreement form for the reasons set forth below and in the Mifepristone Multistate Citizen Petition (FDA-2025-P-1576)
1 awaiting analysis
Requests that the FDA initiate rulemaking to switch ivermectin oral tablet products from prescription-only status to full over-the-counter status.
12 awaiting analysis
Requests that the FDA initiate rulemaking to switch hydroxychloroquine sulfate (HCQ) oral tablet products from prescription-only status to full over-the-counter status.
1 awaiting analysis
Regional Airline Association - Exemption/Rulemaking
How to Prepare a Pre-Request for Designation (Pre-RFD); Availability
1 awaiting analysis
Request that the FDA to revoke all BLA’s for every mRNA COVID-19 vaccine for all demographic groups because manufacturers do not and have never met BLA standards
Endangered and Threatened Wildlife and Plants; 90-Day Findings; Goose Lake sucker