Posts by Leire Zúñiga
January 14, 2025
Guideline for Good Clinical Practice ICH E6 (R3)
The ICH E6 (R3) Guideline reached Step 4 of the ICH process on 06-Jan-2025. This marks a major milestone in the evolution of clinical trials, emphasizing risk management and quality by design across all stages of a study. The E6 (R3) introduces a proportionate, risk-based approach, allowing trial activities to align with the complexity and […]
January 14, 2025
FDA Draft Guidance Protocol Deviations for Clinical Investigations
In December 2024, the FDA published a draft guidance titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices.” This guidance provides practical recommendations to standardize the management and reporting of protocol deviations in clinical trials. It emphasizes identifying deviations that could impact participant safety or data integrity, ensuring a consistent approach across […]
January 7, 2025
FDA Issues Draft Guidance on AI Use in Regulatory Decision-Making
Yesterday 6th January 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the Use of Artificial Intelligence in Drug and Biological Product Development.” This document provides insights and recommendations on incorporating AI technology into generating safety, efficacy, and quality data to support regulatory decisions. The guidance emphasizes transparency in […]