CDER Publishes Drug Safety Priorities

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FDA’s Center for Drug Evaluation and Research provides an update on its safety initiatives.

FDA’s Center for Drug Evaluation and Research (CDER) published an updated CDER Drug Safety Priorities: Initiatives and Innovation report on Oct. 3, 2016 that highlights some of the accomplishments the agency has achieved to date to ensure the safety of drug products.  The report provides updates on CDER’s JumpStart program and Sentinel System.

The report details FDA’s mission for ensuring drug safety and protecting public health. Included in the report is a description of the steps leading to drug approval and FDA’s varied initiatives for keeping the approved drug safe, including postmarketing surveillance and reporting systems.

JumpStart, which provides CDER’s review team with submission data early in the submission process, has provided reviewers with 30 full-service training sessions. The assessment of integrating clinical trials data with JumpStart began, and the Janus Clinical Trials Repository (CTR) data warehouse provided access to study data. The report states that the “use of CTR was explored to facilitate analyses of safety risk across classes of drugs or focused on specific treatment indications.”

Milestones achieved for the Sentinel System, an integrated electronic monitoring system, include the integration of the Active Risk Identification and Analysis (ARIA) System into FDA’s day-to-day regulatory and review activities. ARIA evaluates safety signals by using existing analysis methods and Sentinel’s Common Data Model. ARIA was used to run nearly 2000 different medical product scenarios and to access electronic healthcare data of more than 193 million health plan members. CDER coordinated with the Center for Biologic Evaluation and Research to expand vaccine and blood product surveillance under the Postmarket Rapid Immunization Safety Monitoring and Blood Surveillance Continuous Active Network. 


“FDA is evolving a drug safety enterprise that leverages gains achieved within the agency as well as through alliances with our federal partners and with numerous stakeholder organizations,” states CDER Director Janet Woodcock in the report’s introduction. “The report seeks to offer a broad picture of current safety efforts and highlights the critical advantages gained in safety science through a range of multidisciplinary collaborations and partnerships-within CDER and across the FDA, and with stakeholders from other government agencies, patient communities, industry, and academia,” the agency said in a press release.

Source: FDA