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Public Citizen Wont Retract LipoTron Complaints

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Public Citizen says it stands behind its comments alleging that Advanced Aesthetic Concepts is apparently promoting and distributi...

FDA Has Ethical Responsibilities in Postmarketing Studies: IoM

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Members of the Institute of Medicine committee that studied the ethics of postmarketing trials say that FDA has an ethical respons...

GI Dynamics Diabetes Trial Conditionally Approved

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GI Dynamics gains conditional approval to begin a pivotal clinical trial involving its EndoBarrier, which is being evaluated for t...

FDA Grants Orphan Status for Xoma Drug

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FDA grants Xoma Corp. an orphan drug designation for gevokizumab, an IL-1 beta modulating antibody for treating uveitis.

BMS Scraps Hepatitis C Drug After Patient Death

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Bristol-Myers Squibb stops developing an investigational hepatitis C compound called BMS-986094 due to heart and kidney toxicity-r...

Comments Sought on DTC Advertising Research

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Federal Register Notice: FDA seeks comments on research on consumer understanding of composite endpoint scores in direct-to-consum...

FDA Permanently Debars Shrum

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Federal Register Notice: FDA issues an order permanently debarring Kelly Dean Shrum from providing services to any person with an ...

Science Board to FDA to Meet

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Federal Register Notice: The Science Board to the FDA will meet 10/3 to discuss a new subcommittee to evaluate the challenges iden...

IoM Report on FDA Role in Accelerating Product Development

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The Institute of Medicine releases a summary report of a June workshop on Maximizing Goals of the Cures Acceleration Network to Ac...

Medtronic Cant Claim Preemption in California Case

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A California court denies Medtronic summary judgment in a case in which the company said that federal law preempts state law cover...