University of Mississippi Clinical Trials and FDA Administrator
Daniel M. Riche, Pharm.D., BCPS, CDE
Associate Professor of Pharmacy Practice
The University of Mississippi School of Pharmacy
Assistant Professor of Medicine
Clinic Coordinator, Cardiometabolic Clinic
The University of Mississippi Medical Center
2500 North State Street
Jackson, MS 39216
Phone (601) 984-2640
Fax (601) 984-2751
The FDAAA 801 Requirements page provides summary information on the clinical trial registration and results submission requirements described in Section 801 of the Food and Drug Administration Amendments Act (PDF), known as FDAAA 801. It includes information about Responsible Party, Applicable Clinical Trials, deadlines for submitting required information, and penalties. It includes information on:
- Who Is Responsible for Registering Trials and Submitting Results?
- Which Trials Must Be Registered and Have Results Submitted to ClinicalTrials.gov?
- When Do I Need to Register and Submit Results?
- Are There Penalties If I Fail to Register or Submit Results?
- Other FDAAA 801 Requirements: NIH and FDA
- Development of Regulations to Implement FDAAA 801
For details about the data submission process, see How to Register Your Study and How to Submit Your Results. For descriptions of data elements, see the Protocol Data Element Definitions and Basic Results Data Element Definitions.