Gastroenterologia

Flexible approaches for artificial pancreas system clinical trials

The U.S. Food and Drug Administration issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes. To facilitate development of this novel product in an evolving area, the draft guidance provides flexible recommendations for design and testing that meet statutory requirements for safety and effectiveness. For example, the draft guidance provides for flexibility in choice of study endpoints, number of patients to be studied and the length of the clinical trial.
Approfondisci

 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc...

Food and Drug Administration