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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. 31, 2022; CDRP start, FY 2023; Public workshop, by July 31, 2025; Strategy document published, by April 30, 2026.

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Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

They also noted a distinction in telehealth practices between remote consultations in different states and using telehealth to treat patients who live nearby. The Endocrinology, Diabetes and Metabolism Board received an overview of the team’s current projects.

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“TAP Dancing” Towards Faster Device Commercialization: CDRH’s Total Product Life Cycle Advisory (“TAP”) Program

FDA Law Blog

According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving. Review teams already appoint a lead reviewer to each submission and sometimes assign a project manager to an extensive project.

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California’s Much-Touted IVF Law May Be Delayed Until 2026, Leaving Many in the Lurch

Physician's Weekly

Gavin Newsom has asked lawmakers to push the implementation date to January 2026, leaving patients, insurers, and employers in limbo. If this does not happen before July 1, Arrezola said, the Department of Managed Health Care would enforce the mandate as it exists.