The Evaluability Assessment of the Developing Experiment in Post-Marketing Surveillance of Prescription Drugs

摘要

The report describes the context within which a regulatory administrative experiment is being developed by the Experimental Technology Incentives Program (ETIP) and the Food and Drug Administration (FDA). The purpose of the experiment is to determine the impact on drug development approval of new methods of gathering and analyzing data after a drug is marketed. The report assesses the evaluability of the experiment, raising measurement considerations and proposing means for evaluation.