Federal Register notice: FDA classifies intense pulsed light devices for managing dry eye into Class 2 (special controls).
A just-released FDA memo to commissioner Robert Califf and chief scientist Namandj Bumpus recommends that they order the withdrawal of Covis Pharmas M...
FDA accepts for review an Intercept Pharmaceuticals NDA resubmission for obeticholic acid for use in treating patients with pre-cirrhotic liver fibros...
Medtronic updates a 2022 recall of its HeartWare Ventricular Assist Device System batteries and is now requesting the return of 12 batteries for ongoi...
FDA plans a 4/19 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a postmarketing requirement issued to NDA application ho...
Federal Register notices: FDA issues two orders debarring Linda Godding and Mark Godding for five years from importing or offering for import any drug...
FDA lifts a clinical hold against Astellas Pharma and its FORTIS Ph1/2 clinical trial evaluating AT845, an adeno-associated virus gene replacement the...
The International Conference on Harmonization posts a final guide entitled Quality Risk Management Q9 (R1), which has been adopted by FDA for implemen...
