FDAnews Drug Daily Bulletin

Breaches of a trial contract can result in an FDA inspection and invalidate the data gathered at a trial site. “If people don’t follow the protocol, they don’t do informed consent, they don’t monitor, they don’t keep track of investigational product. ... It certainly can give rise to a breach of contract,” David Rosen, a former FDA official and an attorney and co-chairman of the life sciences industry team at Foley & Lardner, said during an FDAnews webinar.
Clinical Trials Advisor