Useful links from NCRA

US Regulatory Agencies & Resources

• American Nutraceutical Association
• Association of Clinical Research Professionals
• Clinical Trials Registry
• Drug Information Association
• (FDA) US Food and Drug Administration
• Bioresearch Monitoring Information System File
• Clinical Investigator Inspection List
• FDA Information Sheets for IRBs, Clinical Investigators, & Sponsors
• Reporting Complaints About FDA-Regulated Clinical Trials
• FDA Debarred Persons List
• FDA Disqualified/Restricted/Assurance List
• Requesting Information and Records From FDA
• FDA Center for Devices and Radiological Health (CDRH)
• CDRH Device Advice
• CDRH Guidance Documents
• FDA Warning Letters
• FDA Premarket (PMA) Database
• MedTech
• Regulatory Affairs Professionals Society (RAPS)
• Society of Clinical Research Associates, Inc.
• Society of Quality Assurance (SQA)

OUS (Outside US) Regulatory Agencies & Resources

• Australian Government Department of Health and Aging
• Australian Therapeutic Goods Administration
• Canadian Drugs and Health Products
• European Agency for the Evaluation of Medicinal Products
• Global Harmonization Task Force
• Conference on Harmonization
• Japanese Ministry of Health, Labour and Welfare