FDA-HST Announces Memorandum of Understanding - August 9, 2004

The U.S. Food and Drug Administration (FDA) and the Harvard-MIT Division of Health Sciences and Technology (HST) have executed a memorandum of understanding (MOU), dated 29 March 2004, which formalizes a collaborative research relationship.

Under the auspices of this MOU, the FDA and HST are collaborating in research that, among other things, seeks to characterize the use of imaging biomarkers in clinical trials and regulatory approval.

“This MOU reflects the mutual interest we and the FDA have in identifying the potential of imaging biomarkers,” said A. Gregory Sorensen, HST faculty member and the director of the MGH-HST Center for Biomarkers in Imaging. “Bringing together the strengths of the academic community and the FDA to critically examine the strengths, weaknesses, and possibilities of imaging biomarkers will allow us to better understand how to use these new tools to improve the development of novel therapies.”

The announcement, which appeared in the 2 August 2004 Federal Register (v. 69, no. 147, p. 46157) can be found at http://www.fda.gov/OHRMS/DOCKETS/98fr/04-17513.pdf or (Download .pdf here)

The MOU can be viewed in its entirety at
http://www.fda.gov/OHRMS/DOCKETS/98fr/ora0410-n000001.pdf or (Download .pdf here)