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Public Citizen Wants to Silence Advisory Committee Chair

[ Price : $8.95]

Public Citizen wants a ban on FDA advisory committee members making presentations to industry on how best to get a favorable decis...

U.S. Oncology, BioMarin Begin Phase 3 Study in BRCA Breast Cancer

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U.S. Oncology Research and BioMarin Pharmaceutical collaborate to launch a Phase 3 study of BMN 673, a poly ADP-ribose polymerases...

FDA Releases Therapeutic Area Standards Plan

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Federal Register Notice: FDA makes available the Therapeutic Area Standards Initiative Project Plan.

Guidance on Nucleic Acid Tests to Reduce West Nile Virus

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Federal Register Notice; FDA releases a draft guidance on the use of nucleic acid tests to reduce the transmission of West Nile Vi...

Guidance on Active Control Animal Drug Studies

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Federal Register Notice: FDA releases a guidance: Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for...

Panel to Discuss Vandas NDA for Sleep-Wake Disorder

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/14 to discuss a Vanda Ph...

Public Meeting on Meta-Analyses to Assess Trial Safety

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Federal Register Notice: FDA plans a public meeting 11/25 to obtain input on using meta-analyses of randomized controlled clinical...

Panel to Discuss Genzyme sBLA for MS

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Federal Register Notice: FDAs Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/13 to discuss a Genzyme ...

Draeger Anesthesia Machine Recall is Class 1

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FDA says a Draeger recall of Medical Fabius series anesthesia machines is Class 1.

B&L Whistleblower Gets 2nd Chance to Make Case

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The 11th Circuit appeals court returns to a lower court a Bausch & Lomb whistleblower case to determine if a causal connection exi...