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The CDER Drug Safety Priorities 2021 report details CDER's work to manage drug safety issues through modernized safety surveillance methods and innovative responses to safety concerns. The report highlights key safety-related milestones and accomplishments of 2021, as well as the many ways in which CDER has continued to be involved in promoting and protecting public health during the SARS-CoV-2 coronavirus (COVID-19) pandemic. The report focuses on the programs and initiatives at the core of CDER's drug safety operations, including the FDA Adverse Event Reporting Systems, the Sentinel System, and the Safe Use Initiative. It also features ongoing activities to address the national opioid crisis and misuse and abuse of other substances, work in addressing unexpected -- and potentially cancer-causing -- impurities in medicines, use of a broad range of communications tools and technologies such as Drug Safety Communications to transparently communicate drug safety to the public, and research being conducted CDER-wide to better understand drug safety risks.
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