Blue Forest Farms, LLC – 711990 – 09/11/2025

Unapproved New Drugs/Misbranded/Botox

GDUFA User Fee Lists

GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems

Resources and information for requestors interested in CDER’s Clinical Outcome Assessments (COA) Qualification Program.

This update contains the Letter of Intent Template for the COA Qualification Program, as described under section 507 of the Federal Food, Drug, and Cosmetic Act.

New Drug/Misbranded

CENTER VALLEY, Pa., (September 19, 2025) — Olympus Corporation has announced a voluntary, global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) manufactured prior to May 12, 2025, after receiving reports of device components detaching during procedures