FDA CDER Unveils Ambitious 2020 Guidance Agenda

FDA Headquarters

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