Regulatory document library

See also: Regulatory communications

Drug labels

See also: history of changes to adverse effects on the Propecia label

Applications and approvals

See also: How to access clinical trial data from RIAT Initiative (Restoring Invisible & Abandoned Trials).

Propecia

Propecia approval documents – Drugs@FDA

Proscar

FDA Advisory Committee meetings

Dermatologic and Ophthalmic Drugs Advisory Committee, Center for Drug Evaluation and Research, Food and Drug Administration. Meeting No. 48 regarding Propecia, sponsored by Merck. November 13, 1997. Archived

Oncologic Drugs Advisory Committee, Center for Drug Evaluation and Research, Food and Drug Administration. Meeting re: efficacy and safety of Proscar and Avodart for reducing the risk of prostate cancer on December 1, 2010. Archived