Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly

FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine

The Data Standards Strategy reinforces CDER’s ongoing commitment to the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the efficient and effective review of regulatory submissions. This helps bring safe and effective products to market.

Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.

CGMP/Finished Pharmaceuticals/Adulterated

How is a medicine approved by FDA?, How can I find out if my medicine is approved by FDA?

List of compounding policy documents and related materials