This webinar reviews U.S. Food and Drug Administration (FDA) notices of noncompliance. The presenter discusses modernization of the Protocol Registration and Results System (PRS) which is used to register protocols and submit results to the ClinicalTrials.gov database. He also draws on his experience to identify common pitfalls to avoid noncompliance.

Learning Objectives:

- Review recent FDA notices of noncompliance.
- Identify and mitigate potential noncompliance pitfalls.
- Discuss modernization of the Protocol Registration and Results System (PRS) and database by the National Library of Medicine (NLM).

Presented by: Anthony Keyes, MBA, PMP - Johns Hopkins University

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