The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...

The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...

The Food and Drug Administration has delayed a promised review of safety data for the abortion drug mifepristone at Commissioner Marty Makary’s request to put it off until after the midterm elections, ...

Former Food and Drug Administration commissioners said new vaccine standards threaten to put Americans’ health at risk and upend the agency’s scientific integrity. The 12 former FDA leaders criticized ...

The U.S. Food and Drug Administration says it is deploying agentic AI capabilities for all agency employees to enable the creation of more complex AI workflows and assist with multi-step tasks.

The U.S. Food and Drug Administration plans to change how COVID vaccines and other shots are approved and administered. The memo, which was written by FDA chief medical and scientific officer Vinay ...

This is the repository of the jounal paper titled "Integrating Explainable Artificial Intelligence and Carcinogenic Potency Characterization for Safer Nitrosamine Risk Assessment in Drug Synthesis." ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — The Food and Drug ...

WASHINGTON (AP) -- Hormone-based drugs used to treat hot flashes and other menopause symptoms will no longer carry a bold warning label about stroke, heart attack, dementia and other serious risks, ...