Archived documents

FDANotice

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Required Warnings for Cigarette Packages and Advertisements

FDANotice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program

FDANotice

Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period

FDANotice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs

FDANotice

Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Experience Reporting

FDANotice

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments

FDAOther

Citizen Petition from Apotex Inc.

FDAOther

Acknowledgment Letter from FDA DMB Quagen Pharma LLC

FDANotice

Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials; Draft Guidance for Industry; Availability

FDANotice

List of Bulk Drug Substances for which there Is a Clinical Need the Federal Food, Drug, and Cosmetic Act

FDANotice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medication Guides for Prescription Drug Products

FDANotice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Approval of Medical Devices