United States Profile Updated
The United States profile in ClinRegs has been reviewed and updated with the following information:
- Information on the Food & Drug Administration (FDA’s) Electronic Submissions Gateway Next Generation (ESG NextGen) platform, which went live on April 14, 2025 (See Submission Process)
- Department of Justice regulations on certain data transactions involving a country of concern, which took effect in April 2025 (See Personal Data Protection)
- 2024 FDA guidance on charging for drugs under an investigational new drug application (See Submission Content)
- 2024 FDA guidance regarding clinical trials with decentralized elements (See Submission Content, Safety Reporting, Site/Investigator Selection, Risk & Quality Management, Data & Records Management, Documentation Requirements, Required Elements, and Product Management)
- Information on FDA acceptance of foreign clinical studies as support for an investigational new drug application, as well as FDA site inspections (See Scope of Assessment)
- Additional references to FDA regulations, guidelines, and resources related to clinical trial review and implementation were added throughout the profile where appropriate
Sources Added During this Update:
(Guidance) Guidance for Clinical Investigators, Institutional Review Boards and Sponsors: Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations (G-ChldrnSfgrd) (December 2006)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry and Clinical Investigators: The Use of Clinical Holds Following Clinical Investigator Misconduct (G-InvstgtrHold) (September 2004)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND - Frequently Asked Questions (G-FrgnCT) (March 2012)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry and Food and Drug Administration Staff: Collection of Race and Ethnicity Data in Clinical Trials (G-DataCollect) (October 2016)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies - Small Entity Compliance Guide (G-SESftyRprtng) (December 2012)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Charging for Investigational Drugs Under an IND – Questions and Answers (G-IPCharge) (Revision 1) (February 2024)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1) (US-ICH-E3-QA) (January 2013)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Electronic Source Data in Clinical Investigations (G-ESourceData) (September 2013)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations – Questions and Answers (G-ElecSyst) (Revision 1) (October 2024)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products (G-EnrchStrat) (March 2019)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: INDs for Phase 2 and Phase 3 Studies - Chemistry, Manufacturing, and Controls Information (G-CMC-Phase2-3) (May 2003)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry, Investigators, and Other Interested Parties: Conducting Clinical Trials With Decentralized Elements (G-DecentralCT) (September 2024)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry, Investigators, and Other Stakeholders: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (G-RemoteData) (December 2023)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies (G-ExplrtryIND) (January 2006)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application (G-Part11) (August 2003)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds (G-HoldResp) (Revision 1) (October 2000)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials (G-CentralIRB) (March 2006)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Institutional Review Boards and Clinical Investigators: Recruiting Study Subjects (G-SubRecruit) (January 1998)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for IRBs, Clinical Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another IRB (G-IRBTransfer) (May 2014)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance For IRBs, Clinical Investigators, and Sponsors: FDA Inspections of Clinical Investigators (G-FDAInspct) (June 2010)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed (G-IRBResp) (August 2013)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Sponsors, Clinical Investigators, and IRBs: Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials (G-DataReten) (October 2008)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Sponsors, Clinical Investigators, and IRBs: Waiver of IRB Requirements for Drug and Biological Product Studies (G-IRBWaiver) (Updated October 2017)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Form FDA 3674 - Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions (G-3674Cert) (Revised June 2017)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Sponsors, Investigators, and Institutional Review Boards: Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c) (Small Entity Compliance Guide) (G-SEInfrmdCnsnt) (February 2012)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guideline for Industry: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting ICH-E2A (US-ICH-E2A) (March 1995)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guideline for Industry: E3 Structure and Content of Clinical Study Reports (US-ICH-E3) (July 1996)
Food & Drug Administration, US Department of Health & Human Services
(Regulation) Code of Federal Regulations - Title 21, Part 11 - Electronic Records; Electronic Signatures (21CFR11) (Up to Date as of May 16, 2025)
Food & Drug Administration, US Department of Health & Human Services
(Regulation) Code of Federal Regulations - Title 28, Part 202 - Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons (28CFR202) (Up to Date as of May 16, 2025)
US Department of Justice
(Webpage) Bioresearch Monitoring Program Information (USA-20) (FDA reviewed August 4, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Common Rule Departments and Agencies (USA-18) (Last Reviewed May 15, 2025)
Office for Human Research Protections, US Department of Health & Human Services
(Webpage) Exempt Research Determination FAQs (USA-32) (Current as of May 20, 2025)
Office of Human Research Protections, US Department of Health & Human Services
(Webpage) Getting Started with ESG NextGen - User Guides (USA-37) (FDA reviewed May 2, 2025)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) ICH Guidance Documents (USA-22) (FDA reviewed December 11, 2024)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) ICH Guideline Implementation (USA-19) (Current as of May 20, 2025)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Webpage) Importing Human Drugs (USA-23) (FDA reviewed October 9, 2024)
Food & Drug Administration, US Department of Health & Human Services
Sources Revised During this Update:
(Guidance) Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (G-PharmeCTD) (Revision 8) (September 2024)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Institutional Review Boards and Clinical Investigators: Institutional Review Boards Frequently Asked Questions (G-IRBFAQs) (February 2025)
Food & Drug Administration, US Department of Health & Human Services
Guidance) Guidance for Institutions and IRBs: Institutional Review Board (IRB) Written Procedures (G-IRBProcs) (February 2025)
Food & Drug Administration, US Department of Health & Human Services
(Regulation) Code of Federal Regulations - Title 45, Part 46, Subparts B through E (45CFR46-B-E) (Up to Date as of May 16, 2025)
US Department of Health & Human Services
(Document) Dangerous Goods Regulations (USA-21) (66th Edition) (Effective January 1, 2025)
International Air Transport Association, Montreal, CA and Geneva, Switzerland (Note: This document is available for purchase only.)
(Document) Technical Instructions for the Safe Transport of Dangerous Goods by Air (Doc 9284) (USA-10) (2025-2026 Edition) (Effective January 1, 2025 through December 31, 2026)
International Civil Aviation Organization, United Nations (Note: This document is available for purchase only.)
(Form) Form FDA 1571 (3/25): Investigational New Drug Application (IND) (USA-76) (Expires September 30, 2026)
Food & Drug Administration, US Department of Health & Human Services
(Form) Form FDA 1572 (4/25): Statement of Investigator (USA-77) (Expires September 30, 2026)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Electronic Submissions Gateway (USA-44) (FDA reviewed May 19, 2025)
Food & Drug Administration, US Department of Health & Human Services