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FDA publishes a draft International Conference on Harmonization guidance on enhancing the format and structure of benefit-risk inf...[ Price : $8.95]
BIO says an FDA draft guidance on formal meetings between the agency and sponsors of PDUFA products will give additional clarity.[ Price : $8.95]
FDA approves a Bristol-Myers Squibb NDA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating patients with ...[ Price : $8.95]
FDA approves an Allergan PMA to market Juvederm Ultra XC, a dermal filler for injection into the lips and perioral area for lip au...[ Price : $8.95]
Federal Register Notice: FDAs Antimicrobial Drugs and the Drug Safety and Risk Management Advisory Committees will discuss 11/5 sy...[ Price : $8.95]
Federal Register Notice: FDAs Pharmacy Compounding Advisory Committee will meet 10/27-28 to discuss ten bulk drug substances nomin...[ Price : $8.95]
Bloomberg News reports that FDA is trying to increase drug company inspections in China to ensure the quality of finished drugs an...[ Price : $8.95]
Federal Register Final order: FDA classifies the steerable cardiac ablation catheter remote control system into Class 2.