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 U.S. Food and Drug Administration is reportedly weighing whether it will place a “black box” warning label on COVID vaccines, according to CNN, despite research and real-world data demonstrating ...
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’s (FDA) top official ignited fresh debate on Wednesday by accusing Dr Anthony Fauci on the “Pod Force One” podcast of suppressing early scrutiny of COVID-19’s ...
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." ...
Dr. Herzberg is a professor of history and director of the drugs, health and society program at the University at Buffalo. Nov. 15, 2025 It’s one of President Trump’s favorite stories: The Democrats ...
FDA sidestepped its usual public process in reviewing warning Rather than convening one of FDA's standing advisory committees on women's health or drug safety, Makary earlier this year invited a dozen ...
WASHINGTON — 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, the Food ...
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