US Profile Updated with FDA Rule on Informed Consent Exceptions

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 Revised During this Update: 

(Regulation) Code of Federal Regulations - Title 21, Part 50 - Protection of Human Subjects (21CFR50) (Up to Date as of August 23, 2024) 
Food & Drug Administration, US Department of Health & Human Services