Tag: FDA

FDA

Regulatory/FDA

Current FDA Voluntary Pre-Publication Rx Ad Review Processes

Current FDA Voluntary Pre-Publication Rx Ad Review Processes

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 […]

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Regulatory/FDA

FDA Issues Long-Awaited Final Rule for DTC Prescription Drug Ads

FDA Issues Long-Awaited Final Rule for DTC Prescription Drug Ads

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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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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Uncategorized

FDA Proposes Increased Consumer Access to Nonprescription Drugs, with Conditions

FDA Proposes Increased Consumer Access to Nonprescription Drugs, with Conditions

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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Legislative

User Fee Legislation Markup Suggests Added FDA Regulatory Authorities

User Fee Legislation Markup Suggests Added FDA Regulatory Authorities

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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General

Clinical Trials Not Sufficiently Diverse – and Diversity Data Often Not Reported

Clinical Trials Not Sufficiently Diverse – and Diversity Data Often Not Reported

May 9, 2022 – New analyses of clinical trials conducted in the United States and in Europe on potential new drugs found that not only were study populations not as diverse as the general population, but that frequently no race or ethnicity data was included in the trial reports, and sometimes not even gender data. […]

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Regulatory/FDA

CMS Sticks to Plan: No Aduhelm Coverage Unless in Clinical Trial

CMS Sticks to Plan: No Aduhelm Coverage Unless in Clinical Trial

April 12, 2022 – Despite roughly 10,000 public comments and intense lobbying regarding a draft national coverage determination for the controversial Alzheimer’s drug Aduhelm, last week the Centers for Medicare and Medicaid Services (CMS) announced it will retain the proposal’s coverage plan: Medicare will only fund prescriptions of Aduhelm for patients enrolled in randomized, controlled […]

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Washington Focus

Biden’s 2023 Budget: Big Increases for FDA, CDC, Pandemic Preparedness

Biden’s 2023 Budget: Big Increases for FDA, CDC, Pandemic Preparedness

April 4, 2022 – The fiscal year (FY) 2023 budget proposed by President Joe Biden last week emphasizes fiscal restraint more than new, big spending programs, but it does ask for increased funding for pandemic preparedness, the Food and Drug Administration (FDA), and projects such as the Cancer Moonshot and the Advanced Research Projects Agency […]

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