FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JULY 7, 2024

To be sure, Table 2 provides a handy visual of the categories of LDTs, the timeline for phaseout, and the scope of enforcement discretion for each test category. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

Physician's Weekly

JUNE 26, 2025

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.

Insurance 52

Insurance Patient-Centered Provider Management 52