United States Updates

USA flag United States Profile Updated

May 20, 2025 - 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 ...

USA flag US Profile Updated with FDA Rule on Informed Consent Exceptions

Aug 27, 2024 - The United States profile in ClinRegs has been updated to include the Food and Drug Administration (FDA)'s final rule on informed consent exceptions for minimal risk clinical investigations, which took effect on January 22, 2024 (See Documentation Requirements). Sources ...

USA flag US Profile Updated

Jan 5, 2024 - 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 ...

USA flag US Profile Updated

Jan 19, 2023 - 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 ...

USA flag US Profile Updated in ClinRegs

Jan 18, 2022 - The United States profile in ClinRegs has been reviewed and updated with the most current requirements. Key updates include:  Data protection requirements (See Quality, Data & Records Management)  Updated guidance on eCTD submissions (See Submission ...

USA flag US Profile Updated in ClinRegs

Jan 20, 2021 - The United States profile in ClinRegs has been reviewed to ensure all information is up to date. The following sources have been added to the profile: Human Subject Regulations Decision Charts (Last Reviewed June 30, 2020) (See Regulatory Authority) Guidance ...

USA flag United States: OHRP Issues Guidance for Research Impacted by COVID-19

Apr 16, 2020 - On April 8, 2020, the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) issued guidance on how HHS human subjects protection regulations (45 CFR part 46) apply to institutional and investigator actions responding to COVID-19. The guidance ...
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