Gottlieb
U.S. Food and Drug Administration (FDA) officials and health care industry leaders say it’s necessary to reassess the standards of evidence and dependability of information during regulatory discussions, Applied Clinical Trials reports.
FDA Commissioner Scott Gottlieb at an Impact of Real World Evidence on Medical Product Development workshop said the FDA must adapt to a new information paradigm in which new data collection tools and new methods to analyze that data are vital.
Click here to read the full report on Applied Clinical Trials’ website.
