Dockets

Recently active federal rulemakings, soonest-closing first.

• 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 dogsFDANonrulemaking
  1 document · 0 comments
• 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.FDANonrulemaking
  2 documents · 0 comments
• 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.FDANonrulemaking
  2 documents · 0 comments
• 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.FDANonrulemaking
  24 documents · 0 comments
• Request that the FDA grant Formal Authorization of Human-Compatible Food-Based Waste Substrates or the Revocation of Sanitary Endorsements for Commercial Feline AnalogsFDANonrulemaking
  2 documents · 0 comments
• 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.FDANonrulemaking
  2 documents · 0 comments