Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
97-8-14 Order Authorizing Subsidy for Increased Program-Wide - re: EAS at Massena, New York
Request that FDA promulgate rules governing the labeling of animal-derived ingredients. Specifically, petitioners urge the agency to require products that contain animal-derived ingredients to be labeled with a disclaimer on the product’s Principal Display Panel (PDP) that states that the product contains animal-derived ingredients, identifying the species in the statement.
Request that the FDA reconsider the classification of dental amalgam fillings into Class II per the FDA's August 4, 2009, Final Rule
Clinical and Patient Decision Support Software
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
General Wellness Products Draft Guidance for Industry and Food and Drug
Investigating out of Specification(OOS)Test Results fr Pharm
Requests that the FDA revoke its actions to approve the Abbreviate New Drug Application 216616, a generic version of Mifepristone, and modify the associated regimen (including the REMS) until the agency determines that it has complied with the various states’ water quality standards as compelled by the CWA
1 awaiting analysis
Requests that the FDA revoke its actions to approve the Abbreviate New Drug Application 216616, a generic version of Mifepristone, and modify the associated regimen (including the REMS) until the agency conducts the required consultation with the United States Fish and Wildlife Service (FWS) and National Marine Fisheries Service (NMFS) (collectively, “the Services”) as compelled by the ESA
1 awaiting analysis
Requests that the FDA revisit the approval of the Abbreviate New Drug Application 216616, a generic version of Mifepristone, to requires the inclusion of a provision in all Prescriber Requirements that a Catch-Kit and Red Medical Waste Bag be included with Mifepristone Prescriptions
1 awaiting analysis
Requests that the FDA within 180 days of the date of this Citizen Petition, 1. Publish a notice in the Federal Register excluding semaglutide from the 503B Bulks List; 2. Rescind in its entirety the Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (“503B Interim Policy”); 3. Exclude semaglutide from Category 1
2 awaiting analysis
Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009