Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
List of Bulk Drug Substances That May be Used to Compound Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals; Request for Nominations
The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels: Draft Guidance for Industry; Availability
Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Draft Guidance for Industry; Availability
Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability
Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability
Request that the FDA publicly release documentation sufficient to establish that the aluminum content in Adacel, Boostrix, Engerix-B, Havrix, Infanrix, Infanrix hexa, Kinrix, Pediarix, Pedvax-HIB, Pentacel, Prevnar-13, Synflorix, and Vaqtais is consistent with amount provided in its labeling and pause distribution of each Subject Vaccine
Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General and Species-Specific Recommendations; Guidances for Industry
Requests that the FDA revise existing regulations and policies to require drug and dietary supplement manufacturers to clearly label whether ingredients used in their products are animal derived or contain animal byproducts.
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.
Proposal to Debar Yayun Chen
Request that the FDA take the following three actions: A) Encourage Novo Nordisk to sign over the FDA rights to manufacture detemir (Levemir) insulin to an organization who will ensure that a biosimilar gets made. This organization could be a non-profit, a contract manufacturer, or other pharmaceutical company to be determined. B) Encourage Novo Nordisk to allow Levemir (detemir) to be purchased