How the FDA Regulatory Team Assists
For FDA consults, drug and device inquiries, and complying with FDA regulatory requirements.
The Office of Ethics and Compliance (OEC) helps clinical researchers comply with FDA regulations and ClinicalTrials.gov requirements.
For FDA consults, drug and device inquiries, and complying with FDA regulatory requirements.
Information for FDA-regulated clinical trials of Investigational New Drugs and Biologics (IND)
Information for FDA-regulated clinical trials of Investigational Devices (IDE)
Resources to help you prepare for an FDA inspection of a clinical trial.
Resources for researchers who create, maintain, and transmit electronic records for FDA-regulated clinical trials.