FDA ISSUES 2019 DRUG SAFETY PRIORITIES ANNUAL REPORT

FDA ISSUES 2019 DRUG SAFETY PRIORITIES ANNUAL REPORT

The CDER Drug Safety Priorities 2019 report details CDER’s work to manage drug safety issues through modernized safety surveillance methods and innovations in how CDER identifies, assesses, and addresses safety concerns. The report highlights key safety-related milestones and accomplishments of 2019, as well as the programs and initiatives at the core of CDER’s drug safety operations, including the Sentinel System and the Safe Use Initiative. The report focuses on CDER’s ongoing activities to help address the national opioid crisis, work in addressing unexpected impurities in medicines, and use of mobile apps and social media platforms to better understand drug safety risks.