FDA Law

JUNE 10, 2024

In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. Provide both completed and planned actions and related timelines.

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FDA Law

MAY 13, 2024

FDA has even gone so far as to maintain that the “real-life clinical performance of a medical product might be more clearly demonstrated through RWD/RWE because a controlled clinical trial often cannot evaluate all applications of a product in clinical practice across the full range of potential users.”

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Medical Clinic Patients IT 111

GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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IT Patient-Centered Illness Education 126

GeriPal

APRIL 4, 2024

In case you miss the introductions at the start of the podcast, Bernie and Laurie are married, and offer wonderful reminiscence of their clinical practice over the last several decades. Bernie Lo discloses being an Honorarium Recipient and consultant for Takeda starting on 01/23/2024.

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Family Families Patient-Centered IT 112

GeriPal

MARCH 27, 2025

Summary Transcript CME Summary A pragmatic trial evaluates the effectiveness of a treatment or intervention in real-world clinical practice. And interesting enough, this is a really fascinating study that just got published in JAMA I M in December of 2024. Outcomes are typically assessed from available records.

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