CDER Publishes Drug Safety Report

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FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

On April 20, 2018, FDA’s Center for Drug Evaluation and Research (CDER) released its second annual Drug Safety Priorities report, which details drug safety initiatives carried out by CDER and FDA. The report highlights drug safety program milestones and gives an update on goals achieved in 2017. Efforts by FDA to ensure drug safety science, surveillance, and oversight are discussed.

Detailed in the report are the agency’s efforts on pharmacovigilance, medication errors, and risk management. According to the report, CDER’s Sentinal System, an integrated electronic system for monitoring drug safety, was completed and posted in September 2017. The report also goes into detail about the agency’s views on how real-world evidence can advance drug safety. An update on the agency’s efforts to combat the opioid crises is also provided.

“Within the larger framework of CDER’s drug safety enterprise, the Center’s longstanding safety programs such as the Safe Use Initiative, the FDA Adverse Event Report System (FAERS), and the Sentinel System continue to advance their important work. These and many other interconnected efforts … maintain, improve, and expand CDER’s safety-related surveillance and regulatory activities on an ongoing basis,” said Janet Woodcock, MD, CDER director, in the report’s introduction.


Source: FDA