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Responsible Corporate Officials Should be Vigilant: Attorneys

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Barnes & Thornburg attorneys say officials in regulated industries must act to prevent and correct any violations of federal law t...

Advaxis Pre-IND Meeting for HER2 Therapy

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Advaxis completes a pre-IND meeting with FDA that discussed the development plan for ADXS-HER2 for treating HER2-expressing cancer...

FDA Approves Promus Element Stent System

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FDA approves Boston Scientifics Promus Element Plus next-generation drug eluting stent system.

Shire Seeks to Move Vpriv Manufacturing

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Shire files an NDA manufacturing supplement seeking approval to begin production of Vpriv (velaglucerase alfa) at its manufacturin...

FDA Could Do More to Combat Economic Adulteration: GAO

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The Government Accountability Office calls for greater FDA efforts to combat economic adulteration of drugs and food.

Guidance on Anticoccidial Drugs in Food-producing Animals

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Federal Register Notice: FDA releases a draft guidance, Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Anim...

Info on FDA Recall Regs Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on FDA recall regulations to the Office of Management an...

Docket Number Corrected in Device Workshop Notice

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Federal Register Notice: FDA corrects a docket number in an 11/7 notice announcing a public workshop on life cycle approaches for ...

Panel to Discuss Dissolvable Tobacco Products

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Federal Register Notice: FDAs Tobacco Products Panel will meet 1/18-20/12 to discuss dissolvable tobacco products.

FDA OKs Transcepts Intermezzo for Insomnia

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FDA approves Transcept Pharmaceuticals Intermezzo for use by people who waken in the middle of the night and have difficulty retur...