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Pew Recommends Practices for Academic Interest Conflicts

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An expert task force convened by the Pew Charitable Trusts makes recommendations for conflict-of-interest policies in academic med...

FDA Approves 1st Generic Cymbalta

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FDA approves seven generic drug manufacturers to market a generic version of Cymbalta to treat depression.

FDA OKs Gore Viabahn Endoprosthesis

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FDA approves W.L. Gores Viabahn Endoprosthesis to treat stenosis or thrombotic occlusion at the venous anastomosis of synthetic ar...

Lawyer Says Still No FD&C Act-FCA Clarity

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Attorney John Fleder says an appeals court decision failed to discuss the potential interplay between the Federal Food, Drug, and ...

Fast Track Status for Lymphoseek

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FDA grants Navidea Biopharmaceuticals fast track status for Lymphoseek (technetium 99m tilmanocept) injection for sentinel lymph n...

CDER Focusing on Increasing Data Integrity Problems

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CDER Office of Compliance deputy director Ilisa Bernstein says the Center plans to place more attention on data integrity problems...

FDA Sends Info on Device QSRs to OMB

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Federal Register Notice: FDA submits a proposed collection of information on medical device current good manufacturing practice to...

Comments Sought on Periodic Safety Report Info

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Federal Register Notice: FDA seeks comments on an information collection associated with submission of periodic safety reports for...

Guidance on Size, Shape of Generic Tablets, Capsules

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Federal Register Notice: FDA releases a draft guidance: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules...

Latest FDA Warning Letters

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In it latest batch of Warning Letters, FDA cites Ameriderm Laboratories, Jubilant HollisterStier, Market Technologies Inc. dba Der...