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Guidance on FISH Test for Specimen Characterization

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Content and Format for Abbreviated 510(k)s for Early Growth Response 1 Gen...

Panel to Discuss Alcon Labs IOL

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Federal Register Notice: FDAs Ophthalmic Devices Panel will meet 11/14 to discuss Alcon Labs PMA for an intraocular lens.

Public Meeting on Female Sexual Dysfunction

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Federal Register Notice: FDA plans a public meeting 10/27-28 on Female Sexual Interest/Arousal disorder.

FDA, NIH Win Award for Meningitis Vaccine Licensing

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FDA and the National Institutes of Health will receive an award for the years most outstanding intellectual property licensing dea...

Judge Dismisses Lawsuit Against FDA by Whistleblowers

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A Washington DC federal judge dismisses a civil lawsuit brought by current and former CDRH whistleblowers because they failed to e...

Otto Bock C-Leg Petition Response Delayed

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FDA says its decision on a petition to reconsider a request to amend and revoke the 510(k) clearance of Otto Bock C-Leg requires a...

FDA Approves Boehringers Spiriva Respimat for COPD

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FDA approves Boehringer Ingelheim Pharmaceuticals NDA for Spiriva Respimat (tiotropium bromide) inhalation spray for treating bron...

FDA Approves AbbVies Humira for Pediatric Crohns

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FDA approves an AbbVie supplemental BLA for Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining cli...

Atty. Urges FDA to State Position on Device Social Promotion

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Attorney Jeffrey Shapiro says FDA and Congress should make clear whether medical device promotion through social media is labeling...

Clarifications Sought in Informed Consent Guidance

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Trade groups and drug companies raise questions and ask for clarifications in an FDA draft guidance on the informed consent inform...