The assessment indicates that the FDA's REMS for prasugrel is inadequate in quality and impact, suggesting a need for improvement in post-approval safety activities.
The evaluation of the prasugrel REMS highlights the need to improve the quality and impact of FDA post-approval activities to maximize drug safety.
Absolute Event Rate: 0% vs 0%
The prasugrel REMS consisted of passive educational materials whose adequacy was evaluated using highly limited, one-time, cross-sectional surveys. Our assessment adds to evidence suggesting the importance of improving the quality and impact of the FDA's post-approval activities to maximize drug safety.
Metkus et al. (Mon,) reported a other. The assessment indicates that the FDA's REMS for prasugrel is inadequate in quality and impact, suggesting a need for improvement in post-approval safety activities.