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Amgen Loses Bid to Delay Sandoz Biosimilar Launch

[ Price : $8.95]

Amgen loses its bid to delay Sandozs market introduction of the first biosimilar product approved in the U.S. a copy of Amgens Ne...

FDA Releasing More Medical Device Info

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CDRH says it has released much more medical device information through its openFDA program that may help spur innovation and scien...

CDER/DIA Meeting on Oligonucleotide-Based Therapeutics

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Federal Register notice: CDER cosponsors with the Drug Information Association a meeting entitled FDA/DIA Oligonucleotide-Based Th...

Drger Medical Recalls Ventilators Due to Battery Problem

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Drger Medical recalls its Evita V500 Ventilator and Babylog VN500 Ventilator due to battery concerns.

Public Comments Sought on Safety Labeling Guidance

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Federal Register notice. FDA seeks public comment on a proposed collection of information regarding its requirements to make safet...

Committee Wants Info on FDA Warfarin Role

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The House Energy and Commerce Committee asks FDA to answer questions about its role in ensuring safety of patients taking Coumadin...

HHS, Others Seek New Human Subject Protections

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A 9/3 Federal Register notice from 16 federal agencies proposes changes to human subject protection rules for clinical research.

Sandoz Opposition Brief on Amgen Move to Delay Biosimilar

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Sandoz files an opposition brief urging the Federal Circuit Court of Appeals to deny an Amgen emergency motion for injunctive reli...

Great Basin Submits Multiplex Panel for FDA Clearance

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Great Basin Scientific files a 510(k) for its Staph ID/R Blood Culture Panel.

Flextronics China Inspection Finds Violations

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FDA warns Flextronics International about Quality System Regulation violations in its manufacturing of patient arrhythmia monitors...