Archived documents

FDAOther

Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance

FDAOther

Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance

FDAOther

Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance

FDANotice

Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY

FDANotice

Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY

FDANotice

Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY

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