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  1. Drug Safety and Availability

Advances in FDA's Drug Safety Programs

Drug Safety is a Key Priority at the Center for Drug Evaluation and Research

CDER Drug Safety Priorities Fiscal Year 2023

CDER Drug Safety Priorities Fiscal Year 2023 is the ninth yearly report describing key safety programs and activities, and illustrating the depth and versatility of drug safety initiatives across the Center and FDA.  The report features the many ways in which CDER continued to be involved in promoting and protecting public health, as well as the ongoing activities to address the national drug overdose crisis.  These efforts included the strategies to address the related crises of overdose deaths and nonmedical use of prescription opioids and other controlled substances, including by supporting the development of evidence-based treatments to effectively manage pain.  Previous CDER Drug Safety Priorities reports, available at the links below, describe actions the Center has taken in recent years to enhance the quality, accountability, and timeliness of its pre- and post-market drug safety decisions—activities that form the foundation for the interdisciplinary scientific teamwork that is a hallmark of FDA’s drug safety oversight today.

Prior Drug Safety Priorities Reports

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