FDAAA 801 Requirements – ClinicalTrials.gov is Expanding

ClinicalTrials.gov was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of Clinicaltrials.gov is to provide patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.
The ClinicalTrials.gov registration requirements were expanded after Congress passed the FDA Amendments Act of 2007 (FDAAA). In September 2016, Health and Human Services issued the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifying and significantly expanding the requirements for registration and submission of results. The session will cover a brief overview of clinicaltrials.gov registration requirements and will specifically address the Final Rules requirements and deadlines for implementation.