FDA Law

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. He suggested that ABIM work with ACR in the future to publish information about practicing rheumatologists to make it easier for patients to seek rheumatology care from certified physicians in their region. The following is a summary report of the spring meeting.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law

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. While the final guidance continues to borrow some IMDRF concepts, it no longer limits Non-Device CDS to software that informs clinical management (per the IMDRF guidelines).

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. The DCP should follow applicable regulations governing human subject protections, where applicable.

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

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

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