FDA Grand Rounds – Anti-biofilm Technologies for Enhancing the Safety of Medical Device Surfaces – 05/29/2025

Prescription drugs should only be purchased from wholesale drug distributors licensed in the United States. Verify licensing through FDA database links.

A newsletter on regulatory science for CDER’s stakeholders

Interviews with experts from FDA’s Center for Drug Evaluation and Research (CDER) on priorities, projects, and initiatives.

FDA has determined that a REMS is no longer necessary to ensure ERA medicines’ benefits outweigh the risk of EFT.

This draft guidance provides information on the implementation of the statutory provision that authorizes FDA to require application holders for certain drug and biological products to make labeling changes based on new safety information that becomes available after approval of the drug.

CGMP/Finished Pharmaceuticals/Adulterated