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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. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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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. Some Approval Committee members serve as mentors for new Item-Writers to provide live feedback and guidance as they learn the process.

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

FDA Law Blog

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” 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. Newsom spokesperson Elana Ross said the state needs more time to provide guidance to insurers on specific services not addressed in the law to ensure adequate and uniform coverage.