Flu Vaccine Adjuvant Safety is Open for Questions
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This story has been removed because it contained factual errors.
Sanofi-Aventis Says More Info Needed in Postmarketing Guidance
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Sanofi-Aventis tells FDA there are aspects of its draft guidance on postmarketing requirements and commitments that need additiona...
Advisors Asked to Evaluate Fampridine SR Efficacy, Safety
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FDA asks the Peripheral and Central Nervous System Drugs Advisory Committee to evaluate safety and effectiveness of Acordas fampri...
Former Biopure Regulatory Affairs Official Sentenced
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A federal court has sentenced a former Biopure regulatory affairs official to 36 months in prison for lying to a federal judge tha...
FDA Publishes Assay Class 2 Special Controls Guidance
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FDA publishes a guidance to support a Class 2 special controls designation for respiratory viral panel multiplex nucleic acid assa...
