2010-06-17

The National Institutes of Health (NIH) Office of Extramural Research recently launched an expanded informational website to help NIH applicants and grantees better understand their roles and responsibilities related to the Food and Drug Administration Amendments Act of 2007 (FDAAA). The statute expands ClinicalTrials.gov (the National Library of Medicine’s clinical trials registry and results database) and imposes new requirements that apply to certain clinical trials, including certain trials supported in whole or in part by NIH funds.

The expanded site provides an overview of FDAAA specifically as it relates to NIH grants and cooperative agreements supporting "applicable clinical trials." The site provides step-by-step guidance to help grantees comply with the statute throughout the lifecycle of their grant and trial. It includes clear descriptions of the NIH-specific "certifications of compliance" with the statute required for all competing applications and non-competing continuation progress reports that include applicable clinical trials. The site also has expanded Frequently Asked Questions, including a new section on results reporting.

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