How the FDA Regulatory Team Assists
For FDA consults, drug and device inquiries, and complying with FDA regulatory requirements.
FDA Regulatory Support
The Office of Ethics and Compliance (OEC) helps clinical researchers comply with FDA regulations and ClinicalTrials.gov requirements.
FDA Drug & Biologic Studies (IND)
Information for FDA-regulated clinical trials of Investigational New Drugs and Biologics (IND)
FDA Device Studies (IDE)
Information for FDA-regulated clinical trials of Investigational Devices (IDE)
FDA Inspections
Resources to help you prepare for an FDA inspection of a clinical trial.
Part 11 Compliance: FDA Requirements for Electronic Records
Resources for researchers who create, maintain, and transmit electronic records for FDA-regulated clinical trials.
International Council for Harmonisation - Good Clinical Practice Guideline (ICH-GCP E6 (R3))
Information and resources for researchers conducting research subject to the updated ICH-GCP E6 (R3) guidelines.