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Federal Register Notice: FDA extends the comment period on a draft guidance on the de novo classification process.[ Price : $8.95]
Gilead Sciences asks FDA to add new Viread (tenofovir disoproxil fumarate) labeling based on five-year data from two open-label Ph...[ Price : $8.95]
A federal appeals court rules against Cody Laboratories and Lannett Co. in their bid to challenge FDAs Unapproved Drugs Initiative...[ Price : $8.95]
FDA approves a Janssen Pharmaceuticals NDA for Xarelto (rivaroxaban), indicated for preventing stroke and systemic embolism in pat...[ Price : $8.95]
FDA reminds healthcare providers and patients of the 11/17 deadline to enroll in the Avandia-Rosiglitazone Medicines Access Progra...[ Price : $8.95]
FDA watchers hope the U.S. Supreme Court will soon put to rest First Amendment arguments surrounding the agencys restrictions on o...[ Price : $8.95]
FDA approves the market return of Octapharmas Octagam [immune globulin intravenous (human) 5% liquid preparation] for use in treat...[ Price : $8.95]
CareFusion recalls its EnVe Ventilator after identifying potential defects that can interrupt ventilation to patients.