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TSE Advisory Committee Agenda Changed

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Federal Register notice: FDA makes significant changes to the agenda and procedure of its 9/18 Transmissible Spongiform Encephalop...

FDAs New Cancer Standard Surprises Genentech

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CDERs Office of Oncology Drug Products surprises Genentech with a request for more information on a new indication for cancer drug...

FDA Catalogs Pharmacogenomic Info in Approved Labels

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FDA creates a table of pharmacogenomic information found in drug labels.

DDMAC Cites Reliants Rythmol Promo Pieces

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DDMAC says two promotional pieces for Reliant Pharmaceuticals Rythmol SR are false or misleading because they fail to include any ...