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Center for Biologics Evaluation and Research is on a roll in enforcing HCT/P regulations, this enforcement trend indicates that FDA is keeping a close eye on the promotion of such products and making sure they are properly classified and undergo appropriate premarket review.
Recent Freedom of Information Act (FOIA) litigation raises an interesting question: When federal agency action requires analyses under a holistic, multi-factor statutory standard, may...
On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule...
On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed...
Reagan-Udall Report of Center for Tobacco Products, notes that CTP’s role is not only protection via regulation but also via educating the public, especially young people. CTP is initiating the development of a comprehensive 5-year strategic plan.