United States Updates
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
United States: FDA and NIH Issue Guidance for Clinical Trials Impacted by COVID-19
Mar 18, 2020 - FDA and NIH Issue Guidance for Clinical Trials Impacted by COVID-19
On March 18, 2020, the Food & Drug Administration (FDA) issued FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic to assist sponsors in assuring the safety of trial participants, ...
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