2023 Meeting Materials, Cardiovascular and Renal Drugs Advisory Committee

CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) after receiving and investigating complaints of device components ejecting or detaching during

Generic medicine facts, questions and answers, and FDA review and approval process.

Laboratory Manual of Quality Policies (ISO 17025 Requirements)

Unapproved New Drugs/Misbranded

The Genetic Metabolic Diseases Advisory Committee (GeMDAC) advises the Commissioner of Food and Drugs or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs and biologic products for human use and as required.

CGMP/Finished Pharmaceuticals/Adulterated