By Applied Clinical Trials Editors
In this article, Characteristics of a Successful IND, IDE the author discusses ways in which your drug or device could be put on hold.
Rasi was forced to step down in November 2014 by the EU Civil Service Tribunal after a panel of experts found the European Commission (EC) had used improper procedures when it had selected him back in 2011.
PCCTC will utilize its services for the review of its cancer research protocols and related study documents.
Washington correspondent Jill Wechsler reports on Janet Woodcock's explanation to Congress last week on the FDA’s lengthy and deliberative process for issuing important policy advisories on biosimilar naming, labeling and interchangeability.
Synowledge specializes in pharmacovigilance, regulatory affairs and information technology services to support biopharmaceutical companies with recording, analyzing and reporting adverse drug events.
An analysis of 10.2 million adverse report records filed with the FDA along with survey of 123 health professionals by Tufts CSDD, found voluntary adverse drug event (ADE) reporting in the United States is incomplete, inaccurate, and inefficient.