U.S. Food and Drug Administration


Medication Guides

Fri, 19 May 2017 10:14:00 -0400

Orange Book Patent Listing Dispute List

Thu, 18 May 2017 13:01:00 -0400

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act of 2012 (FDASIA)

Thu, 18 May 2017 09:29:00 -0400

Drugs@FDA Data Files

Wed, 17 May 2017 15:23:00 -0400

Drugs@FDA Download File (new structure)

Wed, 17 May 2017 15:20:00 -0400

FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)

Tue, 16 May 2017 12:21:00 -0400

CDER Key Officials List

Mon, 15 May 2017 13:20:00 -0400

FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death

Fri, 12 May 2017 11:04:00 -0400