ABIM

JUNE 11, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. After similar explorations in gastroenterology , hematology and medical oncology , ABIM announced the development of several new focused LKAs planned for launch in those areas in 2026.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 24, 2025

Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Of note, they reported that the committees and the task force are ahead of schedule for developing new items to feature on the focused versions of the Hematology LKA launching in 2026.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

FDA Law Blog

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level.

Manufacturing 45

Manufacturing Medical Patient-Centered Appointment 45

FDA Law Blog

NOVEMBER 17, 2022

Koblitz — As was introduced in our recent blog post summarizing the 2022 MedTech conference ( here ), FDA’s Center for Devices and Radiological Health (CDRH) recently announced the launch of a new pilot program, the Voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot ( see announcement attributed to CDRH director Jeff Shuren, M.D.,

Patient-Centered 69

Patient-Centered Provider Medical IT 69

FDA Law Blog

NOVEMBER 21, 2022

patients are “first in the world” to receive innovative medical devices that are of “high-quality, safe, and effective” through “early, frequent, and strategic communications between the FDA and medical device sponsors.” Devices in the Safer Technologies Program (STeP) will be included in FY 2026. By Adrienne R. See Announcement.

Medical 59

Medical Patient-Centered Provider IT 59

Physician's Weekly

JUNE 26, 2025

He directed the patients to seek local help. While it’s possible that Nath’s patients suffered covid vaccine injuries, Marks said, their symptoms were so varied it was hard to characterize a possible syndrome. The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. Kennedy Jr.

Vaccination 52

Vaccination Patient-Centered Government IT 52

FDA Law Blog

FEBRUARY 20, 2025

Interestingly, counsel focused his arguments exclusively on parrying legal attacks, rather than arguing why the rule was necessary to protect patients. These firings will stretch the Centers resources to take on its existing workload, let alone handle thousands of complex and innovative LDTs.

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. During IVF, a patient’s eggs are retrieved, combined with sperm in a lab, and then transferred to a person’s uterus. A single cycle can total around $25,000 , out of reach for many.

Insurance 52

Insurance Patient-Centered Provider Management 52

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate. Controlling Drug Price Increases.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98