Martin (Marty) Makary, MD, MPH is a gastro-intestinal/pancreas surgeon and public policy researcher at Johns Hopkins University. He is a prolific author, writing for The Washington Post and The Wall Street Journal, authoring of three New York Times bestselling books – Unaccountable, The Price We Pay and Blind Spots – and regularly commentating on CNN and Fox News. Dr. […]
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As run-up to FDA’s DTC Prescription Advertising Rule that goes into effect on May 20, 2024, CHC is working with FDA staff to help reinforce current ad review processes available to healthcare marketers and how review of ads will change in May and later this year with its November enforcement date. Watch for our planned […]
Read more The FDA’s final rule for Direct-to-Consumer Prescription Drug Advertisements (released on November 21, 2023) will certainly impact the creative decisions agencies will make about how to structure the agency refers to as the “major statement” or the dual modality of presenting in a balanced or “neutral” manner the drug’s benefits and risks in visually clear, […]
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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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July 11, 2022 – Providing a new pathway for drug companies and consumers that would enable additional drugs to become available without a prescription is the goal of a recent proposed rule from the Food and Drug Administration (FDA). The proposed rule, issued on June 28, would allow the FDA to approve nonprescription drug products […]
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May 17, 2022 – Considering that the Food and Drug Administration (FDA) receives nearly half of its funding from medical product user fees, the timely reauthorization of user fees before the current iteration expires Sept. 30 is paramount to ensuring smooth product review operations. But this “must-pass” legislation opens the door to additional priorities and […]
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