Office of Surveillance and Epidemiology (OSE) - Divisions
Office of Pharmacovigilance and Epidemiology
- Division of Pharmacovigilance I
- Division of Pharmacovigilance II
- Division of Epidemiology I
- Division of Epidemiology II
- Office of Medication Error Prevention and Risk Management
- Division of Medication Error Prevention and Analysis
- Division of Risk Management
Safety Evaluators and Medical Officers in DPV-I and DPV-II detect safety signals and assess safety-related issues for all marketed drug and therapeutic biologic products. They use a variety of surveillance tools including adverse event report data, published scientific literature, and preclinical, clinical, and pharmacologic knowledge of the products to provide scientific and clinical evaluation that leads to various regulatory actions and communications for safe use of the marketed products.
Our epidemiologists review drug safety-related epidemiologic study protocols and study reports that are required of manufacturers as post marketing requirements (PMRs) and commitments; they also serve as the Agency lead in developing and formulating safety-related observational study PMRs directed at drug sponsors both prior to and during the post marketing period. They evaluate safety signals that arise by putting them into the context of drug use, the existing body of evidence in the scientific literature, and by mounting FDA-sponsored epidemiologic studies as needed to quantify and characterize drug safety risks detected through spontaneous reports or through systematic review of the scientific literature.
Drug Utilization Analysis Staff
Our Drug Use Analysts procure, manage and analyze pharmaceutical sales and health care data to describe and characterize drug utilization levels and treatment patterns in the US to support regulatory decision-making in FDA/CDER. The staff maintains an expertise in pharmacy practice, health care delivery, and pharmacoepidemiology principles to evaluate and interpret these data. They also actively research the market for new resources to address unmet needs in understanding the use of medical products in various settings of care. This allows us to provide drug utilization data as a context for drug safety issues, as well as for supporting evaluation of Risk Evaluation and Mitigation Strategies (REMS) and the impact of FDA regulatory actions.
DMEPA is primarily responsible for reviewing proposed proprietary medication names, labels, labeling and Human Factor Studies in order to reduce the potential for medication errors for products prior to approval by CDER. DMEPA also conducts review and analysis of all medication errors that are reported post-marketing to CDER to determine if regulatory actions are needed such as label /labeling revisions, product redesign, or post-marketing communications to stakeholders. DMEPA works with external stakeholders, regulators, and researchers to better understand the causes of errors and the effectiveness of interventions at preventing errors, and provides guidance to industry on drug development considerations from a medication errors perspective.