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FDA Meeting With BDSI/Meda Looks to Revise Pain Drug REMS

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FDA gives positive comments to a BioDelivery Sciences International (BDSI) and Meda proposed revision to a risk evaluation and mit...

Date Added to Pristiq Review Period Notice

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Federal Register Notice: FDA adds a date to an 8/31 Federal Register announcing the determination of a regulatory review period fo...

Guidance on Impact-Resistant Lenses

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Federal Register Notice: FDA releases a guidance, Impact-Resistant Lenses: Questions and Answers.

Guide on New Animal Drugs for Minor Uses/Species

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Federal Register Notice: FDA releases a guidance, Small Entities Compliance Guide Designation of New Animal Drugs for Minor Uses o...

Office of Womens Health Update Planned

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Federal Register Notice: FDA plans a meeting 9/22, Office of Women's Health Update in Washington, DC.

Date Added to Onglyza Review Period Notice

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Federal Register Notice: FDA adds a date to an 8/31 Federal Register notice announcing the determination of a regulatory review pe...

Workshop on Long-Term Nicotine Replacement Therapy

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Federal Register Notice: CDER plans a scientific workshop on the risks and benefits associated with the long- term use of nicotine...

FDA Issues ICH Capillary Electrophoresis Text Info

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FDA publishes an ICH guidance identifying pharmacopeial texts on capillary electrophoresis that can be used interchangeably.

FDA Advisory Panels Harder to Predict

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A Concept Capital analysis for TheStreet says FDA advisory committees are recommending that fewer new drugs and major new indicati...