The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) just laid down the gauntlet in a document promising an active 2020 chock full of guidances addressing a wide swath of healthcare issues, including several zeroing in on clinical trials.
While CDER doesn’t provide much in the way of a timeline, the document is worth perusing to get a sense of current agency priorities. For example, the agency is promising long-awaited guidances on decentralized clinical trials and on the use of monitoring committees in controlled clinical trials.
In addition, CDER is pledging to issue a guidance addressing the use of health technologies for remote data acquisition in clinical trials.
CDER’s wide-ranging guidance agenda also focuses on biostatistics, clinical pharmacology, drug safety, electronic submissions, and generics, among other topics.
Author: Michael Causey