The Food and Drug Administration (FDA) has released a draft guidance for companies developing drugs and biological products aimed at preventing and treating chemotherapy-induced peripheral neuropathy (CIPN) in cancer patients.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.
Simple Explanation
The FDA made a draft guide to help companies make medicines for cancer patients to stop a painful problem called chemotherapy-induced peripheral neuropathy. They want people to share their thoughts about this guide by March 18, 2025.