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Pervasive Under-reporting at ClinicalTrials.gov: Report

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A STAT investigative report finds pervasive clinical trial reporting violations occurring across industry, researchers, academia, ...

FDA Clears LC Bead LUMI Radiopaque Beads

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FDA clears a BTG plc 510(k) for LC Bead LUMI, a radiopaque embolic bead for the embolization of hypervascular tumors and arteriove...

FDA Draft Guide on Head Lice Drug Development

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FDA releases a draft guidance on Head Lice Infestation: Developing Drugs for Topical Treatment that recommends clinical trial desi...

Reciprocal Approval Bill to Speed Access to Therapies: Cruz

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Senators Ted Cruz (R-TX) and Mike Lee (R-UT) introduce the Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act (S. 23...

New Bioequivalence Standards for Generics Needed: Group

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American Enterprise Institute researchers say FDA needs greater transparency on how generic drugs are found to be bioequivalent an...

CDER Record Approvals Can't Be Maintained: Jenkins

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CDER Office of New Drugs director John Jenkins says the Center is seeing record approvals for new molecular entities this year, bu...

PMA Guidance for Glaucoma Devices

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FDA posts a final guidance entitled Premarket Studies of Implantable Minimally Invasive Glaucoma Surgical Devices that outlines re...

Since Our Last Issue ...

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Industry news you may have missed since our last issue.

Boston Scientific Recalls Chariot Guiding Sheath

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Boston Scientific recalls its Chariot Guiding Sheath due to the risk of shaft separation.

Time for an FDA Makeover, Professor Asserts

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Independent Institute Research fellow and University of Tampa assistant professor Abigail R. Hall says its time to rethink FDAs ro...