FDA Related News

Human Drugs

PhRMA Issues with FDA Medical Queries

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

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...

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...

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...

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.

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...

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...

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...

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.

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.