CDER Data Standards Program

The Food and Drug Administration is advising consumers not to purchase or use Fantasy Aphrodisiac Chocolate, a product promoted and sold for sexual enhancement on various websites, including gearisle.com, and possibly in some retail stores.

Fresenius Kabi is correcting Ivenix LVP software due to anomalies that could cause serious patient harm or death

The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.

FDA has issued draft guidance describing the agency’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.

Webpage providing notices of updates to FDA’s STIC webpages for antibacterial and antifungal drugs.

FDA-TRACK: Prescription Drug User Fee Act Meeting Goals Summary