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FDA publishes a draft guidance for industry on developing drugs to treat acute bacterial sinusitis.[ Price : $8.95]
FDA approves a Novartis NDA for Tasigna (nilotinib), indicated for treating patients with Philadelphia chromosome-positive chronic...[ Price : $8.95]
FDA clears an ATS Medical 510(k) for the ATS Simulus Semi-Rigid Annuloplasty Ring for use in mitral valve repair procedures.[ Price : $8.95]
FDA issues a guidance for industry and agency staff answering questions about regulation of impact-resistant lenses for eyeglasses...[ Price : $8.95]
FDA approves a Sorin Group PMA for the Mitroflow Aortic Pericardial Heart Valve.[ Price : $8.95]
Washington Legal Foundation says DDMAC should withdraw an untitled letter claiming a Cymbalta professional mailer was false and mi...[ Price : $8.95]
FDAs September drug safety labeling changes includes a new boxed warning on an increased risk of venous thromboembolism and death ...[ Price : $8.95]
CDRH says silicone gel-filled breast implants are subject to device tracking requirements.