article thumbnail

The ICH E6(R3) Guideline: A Major Update to Good Clinical Practice

FDA Law Blog

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.

article thumbnail

Geriatric Medicine Board Meeting Summary | Spring 2025

ABIM

He emphasized ABIM’s focus on patient-centered standards and promoting high-quality care, as well as ABIM’s commitment to ensuring a diverse governance that reflects the physician and patient population. 4,372 of these (92%) also have a current valid certificate in Internal Medicine.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Q&A: Prioritizing Early Intervention in Pediatric Obesity

Physician's Weekly

The 2023 American Academy of Pediatrics (AAP) Clinical Practice Guidelines has a section that discusses different approaches (eg, virtual visits, including allied providers, thinking about community programs, etc.). We also need to pick up on when a child is gaining weight rapidly or crossing percentiles so we can intervene earlier.

Family 52
article thumbnail

Rheumatology Board Meeting Summary | Spring 2025

ABIM

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. Representatives from the American College of Rheumatology (ACR) joined for a portion of the meeting*.

article thumbnail

From GRP to SIUU – the Evolution of FDA Guidance on Off-Label Dissemination of Scientific Information

FDA Law Blog

These guidances focused on the types of scientific publications (journal articles, reference texts, and in 2014, clinical practice guidelines) and necessary accompanying information that firms could proactively provide in a manner that would not, on its own, constitute evidence of a new intended use.

Clinic 64
article thumbnail

Screening for Dementia: A Podcast with Anna Chodos, Joseph Gaugler and Soo Borson

GeriPal

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. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

Screening 120
article thumbnail

Episode 120: Antiracism in Medicine Series Episode 1 – Racism, Police Violence, and Health

The Clinical Problem Solvers

Pearls Defining Structural Racism Structural racism is a term that acknowledges that racism is perpetuated beyond individual interactions and interpersonal racism, but is present in the systems and policies that govern our everyday lives. Essien, MD, MPH Hosts: Dereck Paul, MS, Utibe R.