Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
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.
Requests that the FDA take the following measures to protect the public from mercury exposure and other risks caused by dental amalgam: (1) Ban dental amalgam, (2) Ban the use of dental amalgam at least in high-risk populations, including children, pregnant women, women who are planning to become pregnant, nursing women, people with neurological disease, people with impaired kidney function
Request that the FDA issue appropriate labeling and risk communication requirements for systemic fluoroquinolone antibiotics
Request that the FDA grant permission to file an abbreviated new animal drug application (ANADA) for a generic soft chewable tablet for Graphiprant that differs from the pioneer product Galliprant (grapiprant tablets), sponsored by Elanco US Inc, under NADA 141-455
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
Requests that the FDA amend 21 CFR § 610.13 by removing references to the Rabbit Pyrogen Test (RPT) and replacing them with language that supports the use of validated, non-animal, human-relevant pyrogen testing methods.
Requests that the FDA Admit "Waste Parity" Status: Formally acknowledge that the active estrogenic metabolites used in approved conjugated equine estrogen (CEE) pharmaceuticals (such as Premarin) are molecularly identical to the raw equine metabolites the Agency classifies as prohibited "filth" under Section 402(a)(3) of the FD&C Act
Requests that the FDA Abolish Prescription Gatekeeping for Biological Baselines; Authorize Low-Potency Access and Establish a Neurodivergent Bodily Sovereignty Waiver.
Requests that the FDA evaluate and assume jurisdiction over GonaCon-Equine and ZonaStat-H as New Animal Drugs.
Requests that the FDA Mandate Specific Labeling Disclosure for Animal Secretions; Issue a Declaratory Ruling on "Misleading" Thresholds; Grant Reciprocal GRAS Status to Sterile Upcycled Biomass.
Request that the FDA take the administrative action to implement minimum RF safety national requirements for MRI devices to increase end-user understanding of the physical locations of RF risks (to better understand and manage those risks) and / or to eliminate the risk of near-field RF burns for MRI patients
Requests that the FDA refrain from approving any ANDA submitted pursuant to an approved suitability petition under section 505(j)(2)(C) of the FD&C Act for dabrafenib mesylate capsules, 150 mg (EQ Base), unless and until the applicant has conducted and submitted to the FDA.