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

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

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By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).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

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective.

Screening 120

Screening Primary Care Patient-Centered IT 120

FDA Law Blog

OCTOBER 10, 2022

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. The guidance provides no rationale for hinging the device status of CDS software on the frequency with which medical information is collected.

Clinic 52

Clinic Medical Provider Patients 52

ABIM

JUNE 24, 2025

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%). Most (49.5%) are in single-specialty group practice or multi-specialty group practice (38%).

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

ABIM

JUNE 4, 2025

Highlights from the data so far show that 91% of respondents are clinically active, with a large majority practicing in hospital- or system-owned offices, private practice or academic faculty practice, and more than half in multi-specialty group practice. Community Practice in ABIM Governance* Erica N.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52