FDA Law Blog

APRIL 14, 2022

The draft MDUFA V commitment letter starts with a 70% goal in FY 2023, but if the de novo decision goal is met in FY 2023 and the fee revenue amount provided for FY 2026 and 2027 is adequate to support performance improvements, FDA plans to increase the goal to 80% in FY 2026.

Provider 40

Provider Clinic Medical IT 40

ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes. ABIM’s website features expansive sections on research related to assessment and clinical outcomes.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 24, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

ABIM

MAY 30, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to inform operations, such as updating exam blueprints, developing policies for initial certification and MOC, and ensuring adequately diverse representation of the profession in research and governance.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

FDA Law Blog

JUNE 14, 2023

In FY 2026 – FY 2027, continue to support products enrolled in previous fiscal years and expand to enroll up to 100 additional products each fiscal year within existing OHTs or expand to additional OHTs, depending on lessons learned from FY 2023 – FY 2025 experience (i.e., up to 125 total products enrolled through FY 2025).

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R. 820.198). .

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

APRIL 3, 2025

I will always, as always, say, you know, you’re welcome to do this in 2026. It always has clinical relevance to practice today. I’m gonna be very brief on the other two because of that warning, but Eric talked me into, in the first year in doing an article on the impact of rudeness on clinical care that. Of course.

IT 65

IT Hospital Screening Patients 65

FDA Law Blog

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. ACLA, of course, confirmed that was true.

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

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.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98