Search Results for keywords:"FDA Guidance"

The Food and Drug Administration (FDA) has released a draft guidance for companies developing drugs and biological products aimed at preventing and treating chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients. CIPN is a painful condition that can disrupt chemotherapy, affecting patients' survival by leading to treatment interruptions or dose reductions. The guidance offers recommendations for clinical trials, including the selection of trial participants and appropriate study endpoints. The public is encouraged to provide feedback on the draft by March 18, 2025, to help shape the final version.

The Food and Drug Administration (FDA) has released draft guidance for the industry on using Artificial Intelligence (AI) to aid in regulatory decisions for drugs and biological products. This guidance explains how AI can be used to produce credible information or data regarding the safety, effectiveness, or quality of these products. It emphasizes a risk-based assessment framework for AI models and encourages early consultation with the FDA to ensure compliance and credibility. The guidance and its proposed recommendations are open for public comment until April 7, 2025, allowing stakeholders to contribute their views on the outlined framework and engagement options with the FDA.

The Food and Drug Administration (FDA) has released a draft guidance titled “Pulse Oximeters for Medical Purposes–Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations.” This document provides advice on testing and labeling pulse oximeters, especially when the device's accuracy can be influenced by factors like skin pigmentation. The FDA seeks comments on this draft by March 10, 2025, before finalizing it to ensure pulse oximeters are safe and effective for diverse users. The guidance is not yet final and aims to enhance the evaluation process for these medical devices.

The Food and Drug Administration (FDA) announced the release of final guidance titled "E11A Pediatric Extrapolation," prepared with the International Council for Harmonisation. This guidance aims to streamline pediatric drug development, focusing on strategies like safety extrapolation and statistical methodologies to ensure safe, effective medicines for children. It replaces a draft guidance from August 2022 and includes updates to study designs and modeling approaches. The public can comment on this guidance, which is accessible through FDA's regulations website.