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FDA Denies Petition on Scrubs as Medical Devices

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FDA denies a petition filed by attorney James Czaban involving the regulation as medical devices of surgical scrubs for daily wear...

PhRMA Issues with FDA Medical Queries

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PhRMA urges FDA to work internationally to harmonize any change in the approach to premarket safety analytics.

Device Shortages Need More Transparency: FDA

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CDRH researchers analyze the causes of medical device shortages before and during the pandemic and call for more information from ...

Coalition for Health AI Meeting Summary

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The Coalition for Health AI releases a summary of stakeholder discussions on issues that could lead to guidance to enable trustwor...

FDA Defends Training/Support of Team Biologics

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FDA defends criticism from three former FDA Team Biologics inspectors who left the agency over working conditions and complaints o...

AG Hair Limited CGMP Issues

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FDA warns Coquitlam, Canada-based AG Hair Limited about CGMP violations in its production of hand sanitizer drugs for the U.S. mar...

CGMP Violations at Glenmark Pharmaceuticals

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FDA warns Glenmark Pharmaceuticals about CGMP violations in its production of finished drugs at a facility in Goa, India.

CGMP Violations in Kari Gran Inspection

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FDA warns Seattle, WA-based Kari Gran, Inc., about CGMP violations and data integrity issues in its production of finished drugs.

FDA Maintains High Bar for P13K Inhibitors

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As a sign FDA is continuing to raise the bar on data needed to gain approval for a PI3K inhibitor, MEI Pharma and Kyowa Kirin deci...

FDA Developed New Covid Drug Surveillance: Study

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CDER researchers describe Covid-19 drug safety surveillance lessons learned.