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FDA releases an FDA-483 listing four observations from an inspection at GlaxoSmithKlines Aiken, SC, consumer healthcare facility.[ Price : $8.95]
Bloomberg Business says that an FDA effort to bring old unapproved drugs under modern regulation can lead to much higher prices fo...[ Price : $8.95]
An FDA drug safety review of Zambons Monurol (fosfomycin) finds no new safety signals related to either parenteral or oral formula...[ Price : $8.95]
FDA approves an Alkermes NDA for Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophreni...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites International Medical Development and MPH Nutrition.[ Price : $8.95]
Federal Register Notice: FDA is making available an Electronic Common Technical Document (eCTD) Technical Conformance Guide, Versi...[ Price : $8.95]
Federal Register Notice: FDA seeks participants in a pilot projfect for application holder of drugs with Risk Evaluation and Mitig...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on the generic drug user fee cover sheet to the Office o...