Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
Requests that the FDA order and/or take an administrative action, as provided in the below proposed order; under the Authority: 5 U.S.C. §551-§558, §701-§706; 15 U.S.C. §1451-§1461; 21 U.S.C. §141-§149, §321-§397, §467f, §679, §821, §1034; 28 U.S.C. §2112; 42 U.S.C. §201, §262, §263b, §264.
Request that the FDA reconsider the classification of dental amalgam fillings into Class II per the FDA's August 4, 2009, Final Rule
Requests that the FDA Limit the Exposure of Refined Carbohydrates used in Industrial Processing in order to Prevent Obesity, Diabetes, and Cardiovascular Disease in Children and Adults
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
Requests that the FDA to review whether its regulatory record for the Medtronic Activa/Percept Deep Brain Stimulation system contains sufficient publicly available information to assess long-term material degradation and associated patient safety risks.
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)
Enforcement Policies for Certain Electronic Nicotine Delivery Systems (ENDS) Marketed Without Premarket Authorization; Guidance for Industry; Availability
Proposal to Debar Andrew Jonathan Morgan
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
Requests that the FDA initiate rulemaking to establish a clear, enforceable regulatory definition and substantiation requirements for the animal-raising claim “pasture-raised” as applied to shell eggs from laying hens.
Requests that the FDA Reverse its decision to classify desiccated thyroid extract (DTE) as a biological product under the PHS Act; Clarify that the August 6, 2025 Notice to Industry; Affirm that natural thyroid products should, if approved, proceed through the drug approval pathway under section 505 of the FD&C Act; regarding the classification and regulation of DTE products
Request that the FDA Immediate Administrative and Enforcement Action Against 503B Outsourcing Facilities Distributing Adulterated and Misbranded Ophthalmic Bevacizumab Products