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NECC Pharmacist Guilty of Racketeering, Fraud

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A Massachusetts federal jury says a New England Compounding Center pharmacist is guilty of racketeering and fraud, but not of seco...

FDA Releases GDUFA Video Education Series

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FDA releases a video series for industry on the 2017 GDUFA reauthorizations new features.

Follea De Novo for Minoxidil Response Test

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Follea says it has submitted to FDA a de novo application for its Minoxidil Response Test.

Trump Mentions FDA Role in Opioid Emergency Declaration

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President Trump declares the opioid abuse crisis in the U.S. to be a public health emergency while briefly mentioning FDAs role in...

Genentech sBLA for Avastin in Ovarian Cancer

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FDA accepts for review a Genentech supplemental BLA for Avastin (bevacizumab) for its use in combination with chemotherapy, follow...

Draft Guide on Breakthrough Device Program

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Federal Register notice: FDA makes available a draft guidance entitled Breakthrough Devices Program; Draft Guidance for Industry a...

FDA Warns Trailer Park Drug Maker

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FDAs Los Angeles District issues a nine-page Warning Letter to an OTC drug manufacturer that allegedly makes topical pain drugs in...

Drug-Drug Interaction Guidances Out

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FDA issues two draft guidances on a systematic, risk-based approach to evaluating drug-drug interactions.

2 Draft Guidances on Drug-Drug Interactions

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Federal Register notice: FDA makes available two draft guidances entitled In Vitro Metabolism- and Transporter-Mediated Drug-Drug ...

FDA Approves sBLA for Soliris Expanded Use

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FDA approves an Alexion Pharmaceuticals supplemental BLA for Soliris (eculizumab) as a treatment for adult patients with generaliz...