Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
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.
Request that the FDA grant Formal Authorization of Human-Compatible Food-Based Waste Substrates or the Revocation of Sanitary Endorsements for Commercial Feline Analogs
Requests that the FDA issue a formal determination regarding the safety and sanitary classification of agricultural-derived products (e.g., corn, wheat, millet, soy) when used as substrates for animal waste versus human waste.
Request that the FDA declare that the drug product, generic ivermectin (1.87%) oral liquid is suitable for submission in an Abbreviated New Animal Drug Application (ANADA)
Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717.
Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry.
Request that FDA order sponsors of immunotherapies for NSCLC to revise their respective Prescribing Information to reflect that patients with ROS1 and RET rearrangements should use targeted therapies as their first line option, relying on its statutory authority under section 505(o)(4) of the FDC Act.