Federal Register notice: FDA announces a 1/16 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a Durect NDA for bupivacain...
FDA clears a Carestream 510(k) for its Dual-Energy imaging technology and its Focus 35C Detector with Image Suite Software for medical imaging.
Apicore asks FDA to require a specific bioequivalence test for ANDAs citing the companys penicillamine capsules.
CDER OPDP lead project manager Jason Cober reviews in a Webinar the types of errors being seen in promotional submissions in eCTD format.
FDA warns Apothecus Pharmaceutical about CGMP violations in the production of combination products.
FDA warns Torrent Pharma about CGMP and other violations in its production of finished pharmaceuticals.
FDA warns Carolina Liquid Chemistries about manufacturing and distributing adulterated and misbranded reagents.
Federal Register notice: FDA announces a 12/5 public meeting entitled 2019 Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and...