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Federal Register Notice: FDA releases a draft guidance: Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.[ Price : $8.95]
FDA clears an Entellus Medical 510(k) for its XprESS Multi-Sinus Dilation System for treating maxillary sinuses in patients aged t...[ Price : $8.95]
An FDA alert warns about intravascular medical devices made by various manufacturers that have the potential for their hydrophilic...[ Price : $8.95]
FDA approves a Boehringer Ingelheim Pharmaceuticals supplemental NDA for Pradaxa (dabigatran etexilate mesylate) for preventing de...[ Price : $8.95]
Federal Register Notice: FDAs Orthopedic and Rehabilitation Devices Panel will meet 2/19 to discuss a PMA for the DIAM Spinal Stab...[ Price : $8.95]
FDA approves an Emergent BioDefense Operations Lansing BLA for a new indication for BioThrax (Anthrax Vaccine Adsorbed) preventin...[ Price : $8.95]
FDA reviewers express major safety/efficacy concerns that may hamper approval of a Biomarin NDA for Kyndrisa (drisapersen) for tre...[ Price : $8.95]
Due to ongoing implementation challenges with a new Clozapine Risk Evaluation and Mitigation Strategies program, FDA extends its 1...