US Profile Updated
The United States profile in ClinRegs has been reviewed and updated with the following information:
- More detailed descriptions of Food & Drug Administration (FDA) and institutional review board (IRB) clinical trial review processes (See Scope of Assessment and Scope of Review)
- Supplementary guidance on investigational new drug application submissions to the FDA (See Submission Process)
- Additional information on sponsor monitoring requirements (See Risk & Quality Management)
Sources Added During this Update:
(Guidance) Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring (G-RiskMntrng) (August 2013)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry and Review Staff: Good Review Practice - Best Practices for Communication Between IND Sponsors and FDA During Drug Development (G-FDAComm) (December 2017)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Providing Regulatory Submissions in Alternate Electronic Format (G-AltrntElecSubs) (Revision 1) (June 2022)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Industry: Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products (G-RWDRWE) (September 2022)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Guidance for Institutional Review Boards and Clinical Investigators: Protection of Human Subjects: Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure (G-IRBExpdtdRev) (November 1998)
Food & Drug Administration, US Department of Health & Human Services
(Guidance) Informed Consent Requirements in Emergency Research (OPRR Letter, 1996) (G-HHS-Emrgncy) (Last Reviewed March 21, 2016)
US Department of Health & Human Services
(Guidance) OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements (G-ComRuleCnsstncy) (November 12, 2020)
Office for Human Research Protections, US Department of Health & Human Services
(Webpage) About OHRP (USA-93) (Last Reviewed February 12, 2016)
Office for Human Research Protections, US Department of Health & Human Services
(Webpage) Biologics Procedures (SOPPs) (USA-95) (FDA reviewed May 12, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) CDER Contact Information (USA-91) (FDA reviewed October 1, 2020)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) CDER Manual of Policies & Procedures | MAPP (USA-96) (FDA reviewed January 18, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Contacts in the Center for Biologics Evaluation & Research (CBER) (USA-90) (FDA reviewed October 20, 2021)
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 December 22, 2021)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) What We Do (USA-92) (FDA reviewed March 28, 2018)
Food & Drug Administration, US Department of Health & Human Services
Sources Revised During this Update:
(Guidance) eCTD Technical Conformance Guide (G-eCTDTech) (Version 1.8) (November 2022)
Food & Drug Administration, US Department of Health & Human Services
(Form) Form FDA 3500A (11/22): MedWatch (USA-75) (Expires June 30, 2025)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Cellular & Gene Therapy Guidances (USA-80) (FDA reviewed November 4, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Clinical Trials Guidance Documents (USA-47) (FDA reviewed October 17, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) ClinicalTrials.gov - Frequently Asked Questions (USA-26) (Last Reviewed August 2022)
National Institutes of Health, US Department of Health & Human Services
(Webpage) Contact OHRP (USA-82) (Last Reviewed February 10, 2022)
Office for Human Research Protections, US Department of Health & Human Services
(Webpage) Development & Approval Process - Drugs (USA-85) (FDA reviewed August 8, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Electronic Common Technical Document (eCTD) (USA-34) (FDA reviewed December 13, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Electronic Regulatory Submission and Review (USA-36) (FDA reviewed January 18, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Electronic Submissions Gateway (USA-44) (FDA reviewed September 2, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) FDA Overview Organization Chart (USA-33) (FDA reviewed January 12, 2023)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) FDA's Role: ClinicalTrials.gov Information (USA-49) (FDA reviewed March 7, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) HHS – Contact Us (USA-83) (Last Reviewed September 21, 2022)
US Department of Health & Human Services
(Webpage) Import Permit Program (USA-31) (Last Reviewed May 27, 2022)
Centers for Disease Control and Prevention, US Department of Health & Human Services
(Webpage) IND Applications for Clinical Investigations: Chemistry, Manufacturing, and Control (CMC) Information (USA-39) (FDA reviewed February 25, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) Investigational New Drug Applications (IND) for CBER-Regulated Products (USA-52) (FDA reviewed October 14, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) MedWatch Forms for FDA Safety Reporting (USA-48) (FDA reviewed September 15, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) New Drug Application (NDA) (USA-43) (FDA reviewed January 21, 2022)
Food & Drug Administration, US Department of Health & Human Service
(Webpage) Prescription Drug User Fee Amendments (USA-45) (FDA reviewed October 27, 2022)
Food & Drug Administration, US Department of Health & Human Services
(Webpage) The HIPAA Privacy Rule (USA-87) (Last Reviewed March 31, 2022)
US Department of Health & Human Services