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Guidance on DNA Vaccines Development

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Federal Register Notice: FDA releases a guidance on considerations for plasmid DNA vaccines for infectious diseases.

Drugs Elderly Impact Missed: GAO

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GAO says FDA does not make clear to medical reviewers that they should assess NDA trial data for representation of elderly people ...

Grassley Wants FDA Safety Oversight Transparency

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Sen. Chuck Grassley asks FDA commissioner Andrew von Eschenbach about reports the agency Drug Safety Oversight Board voted 8-7 to ...

Guidance on Advisors Financial Information

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FDA issues a draft guidance on collecting and disseminating financial interest information from advisory committee members.

Guidance on Developing Sinusitis Drugs

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FDA publishes a draft guidance for industry on developing drugs to treat acute bacterial sinusitis.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

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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

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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...