Tag: Jon Bigelow. Kate Rawson

Jon Bigelow. Kate Rawson

Regulatory/FDA

FTC Proposes Changes to Health Breach Notification Rule to Strengthen Health App Applicability

FTC Proposes Changes to Health Breach Notification Rule to Strengthen Health App Applicability

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 […]

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Regulatory/FDA

4A’s Submits Comments to FTC on Environmental Claims in Marketing (i.e. “Green Guides”)

4A’s Submits Comments to FTC on Environmental Claims in Marketing (i.e. “Green Guides”)

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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Regulatory/FDA

FDA Accelerated Approval Program Is Under Spotlight Again with Makena

FDA Accelerated Approval Program Is Under Spotlight Again with Makena

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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