FDA Clinical Trials Guidance

FDA Guidance: Cancer Trial Eligibility Criteria

The FDA has issued new guidance regarding eligibility criteria for cancer clinical trials, specifically addressing washout periods and concomitant medications. This guidance aims to help sponsors and IRBs develop trials that are inclusive while ensuring participant safety. Comments on the guidance can be submitted at any time.

FDA Final Guidance on Bioresearch Monitoring Inspections

The FDA has issued final guidance detailing processes and practices for Bioresearch Monitoring inspections, as mandated by the Food and Drug Omnibus Reform Act of 2022. This guidance outlines record and information requirements, communication best practices, and inspection conduct for regulated entities.

FDA Guidance: Inclusive Cancer Trial Eligibility Criteria

The FDA has issued new guidance recommending that sponsors and institutional review boards expand eligibility criteria for cancer clinical trials to include a wider range of patients, particularly concerning performance status. This aims to improve the diversity of clinical trial populations and ensure broader applicability of cancer treatments.

FDA Guidance: Cancer Trial Eligibility Criteria - Laboratory Values

The FDA has issued new guidance on cancer clinical trial eligibility criteria, specifically focusing on laboratory values. The guidance aims to help sponsors and institutional review boards select appropriate laboratory values to avoid unjustified exclusions of diverse patient populations.