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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. As stakeholders begin implementing R3, many questions remain regarding its practical application. By Julie Kim & Deborah L.

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Rheumatology Board Meeting Summary | Spring 2025

ABIM

Salahuddin Kazi, MD, Chair, Rheumatology Board The Rheumatology Board , which meets twice a year and is responsible for oversight of policy and assessment in the specialty, held its spring meeting on March 11, 2025. Chrostowski, DNP, APRN, ANP-C , Maryah Mansoor, MD , and Philip Seo, MD , whose terms on the Specialty Board end June 30, 2025.

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Infectious Disease Board Meeting Summary | Spring 2025

ABIM

Erin Bonura, MD, Chair, ABIM Infectious Disease Board The Infectious Disease Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on March 25, 2025. JD , whose terms on the Specialty Board end June 30, 2025.

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Endocrinology, Diabetes and Metabolism Board Meeting Summary | Spring 2025

ABIM

Christine Twining, MD, Chair, ABIM Endocrinology, Diabetes and Metabolism Board The Endocrinology, Diabetes and Metabolism Board , which meets twice a year and is responsible for oversight of policy and assessment in the specialty, held its spring meeting on April 1, 2025. Community Practice in ABIM Governance* Erica N.

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Hematology Board Meeting Summary | Spring 2025

ABIM

Gertz, MD, MACP, Chair, ABIM Hematology Board The Hematology Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on May 2, 2025. Most (49.5%) are in single-specialty group practice or multi-specialty group practice (38%).

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Nephrology Board Meeting Summary | Spring 2025

ABIM

Rodriguez, MD, Chair of the Nephrology Board The Nephrology Board , which meets twice a year and is responsible for oversight of policy and assessment in the specialty, held its spring meeting on March 18, 2025. Adey, MD , and Linda Awdishu, PharmD , whose terms on the Specialty Board end June 30, 2025. Siddharta G.

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FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law Blog

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.