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Medical Devices

Device Shortages Need More Transparency: FDA

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

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Coalition for Health AI Meeting Summary

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

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Biologics

FDA Defends Training/Support of Team Biologics

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

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Federal Register

Priority Voucher Used on Imjudo Approval

Federal Register notice: FDA announces that AstraZeneca redeemed a priority review voucher for Imjudo (tremelimumab), which was approved 10/23.

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Federal Register

Population PK Modeling for Dosing Alternatives Guide

Federal Register notice: FDA makes available a final guidance on pharmacokinetic-based criteria for supporting alternative dosing regimens for program...

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Human Drugs

FDA Urges Oncopeptides to Withdraw Multiple Myeloma Drug

FDA asks Oncopeptides to withdraw the accelerated approval of multiple myeloma therapy Pepaxto (melphalan flufenamide) after a confirmatory trial fail...

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Human Drugs

FDA Accelerated Approvals Down This Year: AP

An Associated Press story says FDA has granted fewer accelerated approval NDAs/BLAs after taking new steps to tighten control over the expedited pathw...

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Human Drugs

AG Hair Limited CGMP Issues

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

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Human Drugs

CGMP Violations at Glenmark Pharmaceuticals

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

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Human Drugs

CGMP Violations in Kari Gran Inspection

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