New FDA Guidances

The federal Food and Drug Administration has been staying busy, posting new guidances, updates, and drafts since late 2025. Colleagues at HRP Consulting Group have posted a compilation of these new releases on their website.

The following will be of particular interest to our research community:

Final Guidance: Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs.

Final Guidance: Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices

Final Guidance: Sponsor Responsibilities — Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies

Final Guidance: Process and Practices Applicable to Bioresearch Monitoring Inspections. These inspections, also called “BIMO inspections,” are the study-specific reviews the FDA does of the conduct and reporting of FDA-regulated research.