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OMB OKs Info on Health and Diet Survey

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information, Health and Diet Survey.

Comments Sought on Registration of Drugs/Producers in Distribution

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Federal Register Notice: FDA seeks comments on a proposed collection of information on registration and listing of drug producers ...

Guidance on Frequent Blood Donor Questionnaires

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Federal Register Notice: FDA releases a draft guidance on implementing abbreviated donor history questionnaires to frequent blood ...

Oncologic Panel to Discuss 2 NDAs

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Federal Register Notice: FDAs Oncologic Drugs Advisory Committee will meet 12/7 to discuss Pfizers Inlyta for renal cell carcinoma...

FDA OKs Zyprexa/Zyprexa Zydus Generics

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FDA approves generic versions of Lillys Zyprexa and Zyprexa Zydus to treat schizophrenia and bipolar disorder from manufacturers D...

Beyond Surrogate Endpoints: Woodcock on Options

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CDER director Janet Woodcock tells an FDA workshop she has never liked the emphasis on surrogate endpoints in clinical trials, and...

Pfizer Settles Detrol Whistleblower Suit

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Pfizer agrees to pay $14.5 million to settle a whistleblower lawsuit alleging improper marketing of Detrol and Detrol LA.

FDA Accepts Neoprobe NDA fpr Lymphoseek

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FDA accepts for review a Neoprobe NDA for Lymphoseek (tilmanocept) for use in intraoperative lymphatic mapping.

Another Safety Alert on Zyvox, Methylene Blue

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A new FDA drug safety alert warns about a potential drug interaction between Zyvox or methylene blue and serotonergic psychiatric ...

FDA OKs Label Update for Prezista

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FDA approves a label update for Janssen Therapeutics' Prezista (darunavir) tablets to include 192-week data from the company's ART...