On May 18, 2023, the Federal Trade Commission (FTC) announced its intention to issue proposed amendments to the federal Health Breach Notification Rule (HBNR), with the goal of trying to improve patient privacy protections for Americans utilizing digital health apps. Published on May 22, 2023 in the Federal Register, the public has a 60-day window to comment on the […]
Read more On April 24, 2023, the 4A’s submitted written comments to the Federal Trade Commission (FTC) regarding advertising agency recommendations for potential updates to the FTC Green Guides. The FTC published a Request for Comment in December 2022 to seek public input into potential updates and changes to the Green Guides for the Use of Environmental Claims. The FTC Green […]
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Oct. 28, 2022 – The Food and Drug Administration’s (FDA’s) accelerated approval process is being scrutinized anew following a recent FDA advisory committee recommendation to remove from the market Covis Pharma’s Makena, a drug that received an accelerated approval in 2011 to help prevent pre-term births. According to a September report from the Office of […]
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March 7, 2022 – Newly appointed Food and Drug Administration Commissioner Robert Califf, M.D., who is returning to the position he briefly held during the Barack Obama administration, faces a daunting challenge as he begins anew: coming to terms with how the agency’s controversial accelerated approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease affects […]
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