ABIM

JUNE 12, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Community Practice in ABIM Governance* Erica N. The following is a summary of the spring meeting.

Board-Certified 52

Board-Certified Internal Medicine Government Community 52

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Representatives from the American College of Rheumatology (ACR) joined for a portion of the meeting*.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

MAY 30, 2024

The 340B statute requires drug manufacturers to sell certain drugs at discounted ceiling prices to covered entities, which are defined by statute to include certain types of safety net hospitals, health centers, and clinics receiving federal grants. We have blogged about this controversy in previous posts (see e.g., here and here ).

Manufacturing 59

Manufacturing Patient-Centered Government Hospital 59

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law

JANUARY 5, 2023

To date, regulatory enforcement litigation focused on actual or imminent patient harm has taken a backseat to cybersecurity as FDA continues to update and implement its oversight framework. Combination products might be part drug, part device, or part software or hardware.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. EKRA is codified at 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40