FDA warns Orlando, FL-based Cryos International about significant deviations from human cell, tissue, and cellular and tissue-based products regulatio...
FDA also says it expects that many homeopathic drug products will fall outside the categories of drug products that FDA intends to prioritize for enfo...
FDA denies a petition filed by attorney James Czaban involving the regulation as medical devices of surgical scrubs for daily wear by healthcare worke...
PhRMA urges FDA to work internationally to harmonize any change in the approach to premarket safety analytics.
CDRH researchers analyze the causes of medical device shortages before and during the pandemic and call for more information from manufacturers to mit...
The Coalition for Health AI releases a summary of stakeholder discussions on issues that could lead to guidance to enable trustworthy artificial intel...
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 notice: FDA announces that AstraZeneca redeemed a priority review voucher for Imjudo (tremelimumab), which was approved 10/23.
