Monday, April 11, 2016
The FDA lacks reliable, readily accessible data on potential safety issues needed to meet postmarket safety responsibilities and to conduct systematic oversight of new drugs.
This was the conclusion of a recent report issued by the U.S. Government Accountability Office (GAO). The GOA found that the FDA’s Center for Drug Evaluation and Research’s (CDER) internal data evaluations have problems with completeness and accuracy. These problems prevent the timely publication of legally required postmarket studies and reports on tracked safety issues—potential safety concerns the FDA determined to be significant, and which the FDA monitors using an internal database.