US Profile Updated in ClinRegs

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 for Industry: Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans (July 2020) (See Submission Content)
• Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020) (See Trial Initiation)
• Guidance for Industry: Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs (November 2020) (See Trial Authorization)