US Profile Updated
The United States profile in ClinRegs has been reviewed and updated with the following information:
- Updated Food & Drug Administration (FDA) guidance on informed consent (See Risk & Quality Management and the Informed Consent topic)
- Information on the Food and Drug Omnibus Reform Act of 2022, including accelerated approval process changes and clinical trial diversity plan requirements (See Scope of Assessment and Submission Content)
- Supplementary FDA guidance documents related to clinical investigator disqualification, the use of covariates in the analysis of certain clinical trials, major disruptions due to disasters and public health emergencies, safety data collection, a risk-based approach to monitoring, and the use of real-world data and real-world evidence (See Scope of Assessment, Site/Investigator Selection, and Risk & Quality Management)
- Information on the National Institute of Health (NIH)’s privacy and confidentiality policy, as well as the NIH data management and sharing policy (See Personal Data Protection and Risk & Quality Management)
Sources Added During this Update:
(Guidance) Guidance for Industry: Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products (G-CovariatesCT) (May 2023)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers (G-RiskMntrngQA) (April 2023)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products (G-RWDRWE-Reg) (August 2023)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials (G-ICH-E19) (December 2022)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry, Investigators, and Institutional Review Boards: Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies (G-CTEmrgncy) (September 2023)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Clinical Investigator Administrative Actions - Disqualification (G-InvstgtrAdmin) (December 2022)
Food & Drug Administration, US Department of Health & Human Services
(Legislation) Food and Drug Omnibus Reform Act of 2022 (FDORA) (December 29, 2022)
US Congress
(Legislation) Privacy Act of 1974 – 5 U.S.C. 552a: Records Maintained on Individuals (PrvcyAct) (Text in effect as of January 3, 2024)
US Congress
(Policy) Final NIH Policy for Data Management and Sharing (NIHDataMngmnt) (Effective January 25, 2023)
National Institutes of Health, US Department of Health & Human Services
(Policy) NIH Policy Manual - 3014-107 - Privacy and Confidentiality (NIHPrvcy) (Partial Revision Date: June 7, 2021)
National Institutes of Health, US Department of Health & Human Services
(Webpage) Advancing Real-World Evidence Program (USA-17) (FDA reviewed July 25, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Members and Observers (USA-16) (Current as of January 4, 2024)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Webpage) Research Covered Under the Data Management & Sharing Policy (USA-6) (Current as January 4, 2024)
National Institutes of Health, US Department of Health & Human Services
Sources Revised During this Update:
(Guidance) Guidance for IRBs, Clinical Investigators, and Sponsors: Informed Consent (G-InfrmdCnsnt) (August 2023)
Food & Drug Administration, US Department of Health & Human Services
(Document) Dangerous Goods Regulations (USA-21) (65th Edition) (Effective January 1, 2024)
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 (USA-10) (Addendum No. 1) (2023/2024 Edition) (March 31, 2023)
International Civil Aviation Organization, United Nations (Note: This document is available for purchase only.)
(Webpage) CDER Manual of Policies & Procedures | MAPP (USA-96) (FDA reviewed December 21, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Cellular & Gene Therapy Guidances (USA-80) (FDA reviewed December 28, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Contact FDA (USA-81) (FDA reviewed August 17, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Contact OHRP (USA-82) (Last Reviewed August 28, 2023)
Office for Human Research Protections, US Department of Health & Human Services
(Webpage) Electronic Submissions Gateway (USA-44) (FDA reviewed November 29, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) FDA Overview Organization Chart (USA-33) (FDA reviewed October 13, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) FDA's Role: ClinicalTrials.gov Information (USA-49) (FDA reviewed December 4, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Import Permit Program (USA-31) (Last Reviewed December 13, 2023)
Centers for Disease Control and Prevention, US Department of Health & Human Services
(Webpage) Prescription Drug User Fee Amendments (USA-45) (FDA reviewed December 14, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Regulatory Submissions in Electronic and Paper Format for CBER-Regulated Products (USA-94) (FDA reviewed May 23, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Submission of an Investigational New Drug Application (IND) to CBER (USA-53) (FDA reviewed September 29, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) What We Do (USA-92) (FDA reviewed November 21, 2023)
Food & Drug Administration, US Department of Health & Human Services