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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...

Sanofi Sues FDA Over Nasacort OTC Labeling Release

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Sanofi sues FDA seeking to block the release of the approved drug label for its over-the-counter Nasacort Allergy 24-hour nasal sp...

FDA Approves Aptiom for Partial Seizures

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FDA approves a Sunovion NDA for Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epileps...

Draft Hearing Aid/PSAP Guidance Out

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CDRH issues a draft guidance on regulatory requirements applying to hearing aids and personal sound amplification products dependi...

FDA Orphan Status for Patrys Anti-cancer Drug

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FDA grants Patrys Limited an orphan drug designation for its lead anti-cancer product PAT-SM6 for treating multiple myeloma.