FDA Law

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. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

ABIM

JUNE 4, 2025

They also noted a distinction in telehealth practices between remote consultations in different states and using telehealth to treat patients who live nearby. Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

FDA Law

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

FDA Law

JUNE 14, 2023

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. Given Dr. Shuren’s propensity to use the phrase, we have yet to see it formally defined by CDRH.

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law

FEBRUARY 20, 2025

FDA had been scheduled to hold a webinar on the Stage 2 (May 2026) requirements related to the investigational device requirements for LDTs later this month. This raises the question of whether and to what extent, if the rule moves forward, will FDA provide any tools to help laboratories as they seek to comply with these new requirements.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

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