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Alkermes files a supplemental NDA for a two-month dosing interval for Aristada (aripiprazole lauroxil) extended-release injectable...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Adamson Analytical Laboratories, Concept Products, Fallon Wellness Pharmacy, Fin...[ Price : $8.95]
Federal Register Notice: FDA plans a meeting of the General and Plastic Surgery Devices Panel 9/20-21.[ Price : $8.95]
FDAs Microbiology Devices Panel will consider OTC diagnostic devices for three infectious disease pathogens.[ Price : $8.95]
FDAs Los Angeles District Office warns Adamson Analytical Laboratories about violations of CGMP regulations for finished pharmaceu...[ Price : $8.95]
Two Hyman, Phelps & McNamara lawyers say FDA is exercising more regulatory flexibility than is given to it when making accelerated...[ Price : $8.95]
FDA posts a draft guidance on Ulcerative Colitis: Clinical Trial Endpoints that is intended to assist sponsors in their clinical d...[ Price : $8.95]
A new report indicates that many medical device makers are not ready to implement Unique Device Identification labeling based on F...