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Guidance on Developing Sinusitis Drugs

[ Price : $8.95]

FDA publishes a draft guidance for industry on developing drugs to treat acute bacterial sinusitis.

FDA OKs Novartis Leukemia Drug

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FDA approves a Novartis NDA for Tasigna (nilotinib), indicated for treating patients with Philadelphia chromosome-positive chronic...

FDA Clears ATS Medicals Annuloplasty Ring

[ 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.

Impact-Resistant Lens Q&A

[ Price : $8.95]

FDA issues a guidance for industry and agency staff answering questions about regulation of impact-resistant lenses for eyeglasses...

FDA OKs Sorins Heart Valve

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FDA approves a Sorin Group PMA for the Mitroflow Aortic Pericardial Heart Valve.

WLF Challenges Cymbalta Letter

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Washington Legal Foundation says DDMAC should withdraw an untitled letter claiming a Cymbalta professional mailer was false and mi...

Lillys Evista Gets New Black Box Warning

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FDAs September drug safety labeling changes includes a new boxed warning on an increased risk of venous thromboembolism and death ...

Breast Implants Must be Tracked

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CDRH says silicone gel-filled breast implants are subject to device tracking requirements.

FDA Looking at Bupropion Complaints

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FDA looks at consumer complaints about generic Wellbutrin XL and lab tests indicating it releases the active ingredient too fast.

Guidance on Impact-Resistant Lenses

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Federal Register Notice: FDA releases a draft guidance on impact-resistant lenses.