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Study Backs Pediatric Cough Cold Medicine Re-Labeling

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A Centers for Disease Control and Prevention study says emergency department visits associated with OTC pediatric cough cold medic...

Pfizer Rapamune Study Misses Primary End Point

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A Phase 3B/4 study involving Pfizers Rapamune in kidney transplant patients who transitioned from tacrolimus-based therapy (TAC) t...

Fast Track Status for Alnylam Pharmas Patisiran

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FDA grants Alnylam Pharmaceuticals a fast track designation for ALN-TTR02 (patisiran) for treating transthyretin-familial amyloid ...

FTC Workshop to Examine Biosimilar Naming Issues

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The Federal Trade Commission hosts a workshop to examine competition issues surrounding biologic and follow-on biologic medication...

FDA Reviewers Slam Genzyme sBLA Submission for Lemtrada

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FDA reviewers say data in a Genzyme supplemental BLA for Lemtrada (alemtuzumab), indicated for treating patients with relapsing fo...

Info on Animal Feed Standards Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on draft animal feed standards to the Office of Manageme...

Workshop on Sentinel Initiative

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Federal Register Notice: FDA plans a public workshop 1/14/14, Sixth Annual Sentinel Initiative in Washington, DC.

FDA Clears Topera FIRMap Catheter

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FDA clears a Topera 510(k) for its FIRMap Catheter for use on its 3D Mapping System to identify a patients hearts electrical activ...

FDA Proposes Generic Drug Safety Labeling Changes

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FDA issues a proposed rule to require generic drug makers to use the same process as brand drug manufacturers to update safety inf...

FDA Approves Generic Aciphex Copies

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FDA approves the first generic versions of Eisais Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesopha...