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Congressman Complains to Obama About FDA

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Rep. Erik Paulsen complains to President Obama about pending 510(k) approval pathway changes being considered by FDA.

FDA Raises Concerns with Industry MDUFA 3 Proposal

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FDA raises issues about an industry performance proposal as part of MDUFA 3 reauthorization talks.

CGMP Problems at Chinese Drug Manufacturer

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FDA warns Zhejang Casing of CGMP problems at its drug facility in China.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Angiodynamics, Confidence, Nanjing Maohai Biotech, Velocity Pharma, and Zhejiang...

FDA Approves Perrigos Generic Extina

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FDA approves a Perrigo ANDA for ketoconazole foam, 2%, a generic version of Stiefel Labs Extina Foam.

Panel Charter Changed to Include Analgesics

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Federal Register Final rule: FDA changes the name and function of the Anesthetic and Life Support Drugs Advisory Committee.

Guidance on Scored Tablets

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Federal Register Notice: FDA releases a draft guidance on labeling of tablets that have been scored.

Aeterna Zentaris Plans FDA Meeting on AGHD Test

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Aeterna Zentaris says positive Phase 3 trial results for its oral diagnostic test for adult growth hormone deficiency will be revi...

Woman Convicted of Unlawful Stem Cell Sales

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The Justice Department says an Arizona woman pleaded guilty to unlawful distribution of stem cells in interstate commerce.

IVD Group Says FDA Guidance Too Restrictive

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The Association for Molecular Pathology says a recent FDA draft guidance on in vitro diagnostic (IVD) tests could result in reduce...