Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
Esa Breadner - Exemption/Rulemaking
2025 Small Community Air Service Development Program
Requests that the FDA Invite the drug sponsor, Brainstorm Cell Therapeutics, to re-file its Biologics License Application (BLA) for debamestrocel (aka NurOwn), a first-in-class, autologous, mesenchymal stem cell therapy enhanced with neurotrophic factors. Approve debamestrocel for ALS, with a Phase 4 study mandating participation in a biorepository with a natural history and exposome database.
Endangered and Threatened Wildlife and Plants; 90-Day Findings for ten Species; Southwest spring firefly
Requests that the FDA codify, regularize, and transparently administer a principle the Agency already recognizes in practice: that the adequacy of an investigation in rare diseases cannot be determined by default assumptions alone. It does not ask FDA to invent a new principle or apply distinct evidentiary thresholds or concessions to rare disease research programs.
2 awaiting analysis
Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability
Request that the FDA amend the prescription status of triptan medications to allow their availability as over-the-counter (OTC) products for the acute treatment of migraine headaches with or without aura in adults who have a previous diagnosis of migrainie
Shay Hazkani - Third-Party Complaint Against American Airlines
Development of Non-Opioid Analgesics for Chronic Pain, Draft Guidance for Industry; Availability
Requests that the FDA amend the applicable OTC monograph for internal analgesic, antipyretic, and antirheumatic drug products (OTC Monograph M013). Petitioner requests that FDA require all OTC acetaminophen-containing drug products labeled for use in infants and children to include an additional warning and caregiver-directed instruction
SkyWest Airlines, Inc. - Notice of Intent to Terminate Scheduled Air Service at Imperial, California
Guidance for Industry: Questions and Answers on HACCP Regulation for Fish and Fishery Products