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Liberal Think Tank Predicts Tough Times for Pharma

[ Price : $8.95]

A heavyweight Democratic think tank ponders tough times ahead for Big Pharma due to expected changes from the incoming administrat...

REMS Needed for Actemra Approval

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FDA says Roche needs to develop a risk strategy and provide non-clinical animal model data to complete its Actemra BLA for treatin...

FDA Alliance Lauds von E for 2008 Funding Boost

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The Alliance for a Stronger FDA gives commissioner Andrew von Eschenbach a reluctant heros plaudit in the budget battles of 2008 t...

Manufacturing Guidance for Biologics

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Federal Register Notice: FDA releases a guidance on cooperative manufacturing arrangements for licensed biologics.

MVI Adult Injectable Supply Problems Fixed

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Hospira says no further supply issues are expected for MVI Adult Injectable.

FDA Approves BD Pap Test Screening System

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FDA approves a BD Diagnostics PMA for the BD FocalPoint GS Imaging System as an aid in cervical cancer detection.

Gentas Tesetaxel is Orphan Drug

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FDA grants orphan drug status to Gentas tesetaxel, being developed to treat advanced melanoma.

Comments Sought on Device Reclassification

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Federal Register Notice: FDA seeks comments on reclassification petitions for medical devices.

FDA, WebMD Sign MOU to Provide Online Info

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Federal Register Notice: FDA provides a notice of a memorandum of understanding between FDA and WebMD, which will include a joint ...

FDA Working with WebMD on Consumer Information

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FDA and WebMD unveil an agreement for FDA to provide content to be carried in a distinct FDA page on WebMD and in the WebMD magazi...