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Federal Register notice: FDA makes available a draft guidance entitled Breakthrough Devices Program; Draft Guidance for Industry a...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

Bill Would Require HHS Drug Price Negotiations

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Four congressional Democrats introduce a bill to require HHS to negotiate prices for Medicare Part D covered drugs.

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...

FDA Boosting Real-World Data in Cancer Trials

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FDA Oncology Center of Excellence staff outlines steps to promote greater use of real-world evidence in cancer trials.

Lipitor Decision Threatens Patent Settlements: WLF

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Washington Legal Foundation chief counsel Richard Samp criticizes a Third Circuit Court of Appeals decision in a Lipitor patent se...

Lawsuit Ads Can Hurt Public Health: Report

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A U.S. Chamber report outlines steps, including by FDA, that can be taken to restrict lawsuit advertising that it says can harm pu...