Dockets
Federal rulemakings, soonest-closing first — each gathers its documents and comments.
Agency ▾
Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
1 awaiting analysis
Specific Electronic Submissions Intended for FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, and other administrative record submissions) - Comments/Complaints are not to be submitted on this docket ID.
1 awaiting analysis
General Wellness Products Draft Guidance for Industry and Food and Drug
3 awaiting analysis
Brain-Computer Interface Devices for Patients with Paralysis and Amputation; Public Workshop; Request for Comments
4 awaiting analysis
Implementation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009
Clinical and Patient Decision Support Software
2 awaiting analysis
Providing Comments on CDER Level 2 Guidances
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
531 awaiting analysis
The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels: Draft Guidance for Industry; Availability
2 awaiting analysis
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Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability
Investigator Responsibilities--Safety Reporting for Investigational Drugs and Devices; Draft Guidance for Industry; Availability
3 awaiting analysis
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