[ Price : $8.95]
FDA publishes a final guidance to assist sponsors in submitting human factors information with medical device marketing applicatio...[ Price : $8.95]
FDA publishes two final guidances on aspects of establishing bioequivalence.[ Price : $8.95]
Reps. Debbie Dingell and Rich McCormick say FDA should update its strategy for evaluating and identifying sepsis as a means to exc...[ Price : $8.95]
FDA marks the 50th anniversary of the 1976 Medical Device Amendments by highlighting the laws lasting role in shaping the modern o...[ Price : $8.95]
FDA issues an update on a Philips Respironics device correction involving its Trilogy Evo platform ventilators, citing risks that ...[ Price : $8.95]
FDA extends by three months its review timeline of a Beren Therapeutics NDA for adrabetadex for treating infantile-onset Niemann-P...[ Price : $8.95]
FDA approves AstraZenecas Imfinzi (durvalumab) in combination with Bacillus Calmette-Guerin (BCG) for treating adults with BCG-nav...[ Price : $8.95]
BrainStorm Cell Therapeutics names former FDA associate commissioner Peter Pitts to its board of directors.