Dear Members, please note the following FDA Guidance Document updates issued since 15/12/2025:
Final Guidance:
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices | FDA
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | FDA
Processes and Practices Applicable to Bioresearch Monitoring Inspections | FDA
Clinical Decision Support Software | FDA
General Wellness: Policy for Low Risk Devices | FDA
Draft Guidance: Study of Sex Differences in the Clinical Evaluation of Medical Products | FDA
