United States Profile Updated
The United States profile in ClinRegs has been reviewed and updated with the following information:
- 2025 Food & Drug Administration (FDA) guidance regarding sponsor and investigator responsibilities for safety reporting and additional adverse event reporting resources (See Safety Reporting)
- FDA guidance and additional resource on investigational new drug application safety reports (See Safety Reporting)
- Updated and additional resources regarding the FDA’s Electronic Submissions Gateway Next Generation (ESG NextGen) (See Submission Process)
- Additional details on FDA requirements for submitting investigational new drug applications in the Electronic Common Technical Document (eCTD) format (See Submission Process)
- References to the FDA’s implementation of the ICH Guidelines for Good Clinical Practice E6(R3) for drug clinical trials throughout the profile
- Details on the FDA’s Bioresearch Monitoring (BIMO) program (See Scope of Assessment)
- References to FDA resources for Phase 1 investigational new drug applications (See Submission Content)
- Reference to 2025 FDA guidance on enrollment practices to enhance participation in clinical trials (See Initiation, Agreements & Registration)
- Reference to FDA resource regarding the use of artificial intelligence (AI) to advance drug and biological product development (See Risk & Quality Management)
- References to National Institutes of Health (NIH) resources regarding the NIH’s definition of a clinical trial and the NIH’s data management and sharing policy (See Initiation, Agreements & Registration and Risk & Quality Management)
Sources Added During this Update:
(Guidance) Guidance for Industry: Enhancing Participation in Clinical Trials - Eligibility Criteria, Enrollment Practices, and Trial Designs (G-CTPrtcptn) (Revision 1) (December 2025)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Processes and Practices Applicable to Bioresearch Monitoring Inspections (G-BiorsrchInspct) (December 2025)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Providing Regulatory Submissions in Electronic Format: IND Safety Reports (G-INDElecSubs) (April 2024)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies (G-SpnsrRpt) (December 2025)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Investigators, Industry, and Institutional Review Boards: Investigator Responsibilities - Safety Reporting for Investigational Drugs and Devices (G-InvstRpt) (December 2025)
Food & Drug Administration, US Department of Health & Human Services
(Document) Guiding Principles of Good AI Practice in Drug Development (USA-69) (January 2026)
Food & Drug Administration, US Department of Health & Human Services and European Medicines Agency
(Webpage) Data Management and Sharing Policy (USA-97) (Last Updated August 5, 2025)
National Institutes of Health, US Department of Health & Human Services
(Webpage) Electronic Submissions Gateway Next Generation (ESG NextGen) – Industry Unified Submission Portal (USP) Login (USA-102) (Current as of August 14, 2026)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) FDA Adverse Event Monitoring System (AEMS) Electronic Submissions (USA-46) (FDA reviewed April 6, 2026)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) FDA Adverse Event Monitoring System (AEMS) Public Dashboard for Drugs and Biologics (USA-50) (Current as of August 14, 2026)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) IND Application Reporting: IND Safety Reports (USA-99) (FDA reviewed June 23, 2026)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) NIH's Definition of a Clinical Trial (USA-98) (Last Updated August 10, 2026)
National Institutes of Health, US Department of Health & Human Services
(Webpage) Phase 1 Investigational New Drug (IND) Navigator (USA-100) (FDA reviewed June 22, 2026)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Safety Reporting Portal (USA-51) (Current as of August 14, 2026)
Food & Drug Administration, US Department of Health & Human Services
Sources Revised During this Update:
(Guidance) Guidance for Industry: E6(R3) Good Clinical Practice (US-ICH-GCP) (September 2025)
Food & Drug Administration, US Department of Health & Human Services
(Document) NCI Best Practices for Biospecimen Resources (USA-2) (4th Edition) (January 2026)
National Cancer Institute, National Institutes of Health, US Department of Health & Human Services
(Form) Form FDA-3500A MedWatch (09/2025) (USA-75) (Expires September 30, 2027)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Electronic Submissions Gateway Next Generation (ESG NextGen) (USA-44) (FDA reviewed July 31, 2026)
Food & Drug Administration, US Department of Health & Human Services