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A just-released FDA memo to commissioner Robert Califf and chief scientist Namandj Bumpus recommends that they order the withdrawa...[ Price : $8.95]
FDA accepts for review an Intercept Pharmaceuticals NDA resubmission for obeticholic acid for use in treating patients with pre-ci...[ Price : $8.95]
Medtronic updates a 2022 recall of its HeartWare Ventricular Assist Device System batteries and is now requesting the return of 12...[ Price : $8.95]
FDA plans a 4/19 Anesthetic and Analgesic Drug Products Advisory Committee meeting to discuss a postmarketing requirement issued t...[ Price : $8.95]
Federal Register notices: FDA issues two orders debarring Linda Godding and Mark Godding for five years from importing or offering...[ Price : $8.95]
FDA lifts a clinical hold against Astellas Pharma and its FORTIS Ph1/2 clinical trial evaluating AT845, an adeno-associated virus ...[ Price : $8.95]
The International Conference on Harmonization posts a final guide entitled Quality Risk Management Q9 (R1), which has been adopted...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled Accreditation Scheme for Conformity As...