Guide to FDAAA Reporting Research Results
On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act (FDAAA) of 2007. This new law represented a very significant addition to FDA authority. The provisions of section 402(j) of the Public Health Service Act (PHS Act) (42 U.S.C. 282(j)), were added to improve public access to information about certain clinical trials of FDA-regulated products and device, and certain pediatric post-market surveillances of a device. Under section 402(j), those responsible for specified clinical trials of FDA-regulated products were required to submit registration information to ClinicalTrials.gov (December 26, 2007), summary results information for clinical trials of approved products (September 27, 2008), and adverse events information (September 27, 2009).
A Notice of Proposed Rule Making (NPRM), released November 21, 2015 (Comment period ends 3/23/15) (http://www.gpo.gov/fdsys/pkg/FR-2014-11-21/html/2014-26197.htm) expands FDAAA rules regarding registration and results reporting requirements.
While NIH Office of Protocol Services (OPS) assists with Registration, the Responsible Party named in the Registration, is expected to make sure that Research Results are posted to ClinicalTrials.gov within one year of the trial completion date.
NIH Policies Related to the FDAAA NPRM
Please note that the following information is a DRAFT and has not yet been fully approved by the Office of Intramural Research (OIR).
The new NIH Policy on FDAAA requirements applied to extramurally funded Clinical Trials also applies to the Intramural Research Program (IRP). Although there are similarities in the proposed changes to FDAAA listed in the NPRM, there are distinct differences.
- NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
- Questions and Answers on the NIH FDAAA Policy
- NIH Definition of Clinical Trial
- Clinical Trials Case Studies
- Clinical Trials Compliance Agreement
- Assistance Available to Help with Results Reporting to ClinicalTrials.gov
- Compliance Provisions
The page was last updated on Friday, December 11, 2015 - 4:30pm