FDA Law Blog

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Dr. McDonald explained that the LKA provides MOC points for questions answered correctly, but since ABIM is not an accreditation organization, it does not offer CME credit. 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 Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64

Clinic Clinical Practice Provider Utilities 64

FDA Law Blog

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. Criterion 3 : Non-Device CDS software functions are intended for the purpose of supporting or providing recommendations about a patient’s care to a health care professional (HCP) user.

Clinic 52

Clinic Medical Provider Patients 52

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*. Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. Preliminary data show that 90% of respondents are clinically active with the majority in hospital- or system-owned practice (38%), academic faculty practice (32.9%) and private practice (26.8%). Community Practice in ABIM Governance* Erica N.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. They discussed an interest in its ability to collect data specific to practice areas like HIV and geographic areas—like practice ZIP codes—to better understand workforce needs and patterns. Community Practice in ABIM Governance* Erica N.

Board-Certified 52

Board-Certified Government Community Education 52