What NIH Grantees Need to Know About FDAA
Date: November 16, 2011
The Food and Drug Administration Amendments Act of 2007 (FDAAA) (expands the National Library of Medicine (NLM) clinical trials registry and results database known as ClinicalTrials.gov and imposes new requirements that apply to certain trials supported by NIH funds.
Trials subject to FDAAA are called “applicable clinical trials” or ACTs. Any ACT supported in whole or in part by an NIH grant (including cooperative agreements) must be in full compliance with FDAAA.