Signal Detection and Signal Management Activities of the Office of Surveillance and Epidemiology (OSE)
Food & Drug Administration (FDA)
FDA’s Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
FDA Safety Evaluators and Medical Officers in the Office of Surveillance and Epidemiology (OSE) 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 products to provide scientific and clinical evaluations that lead to various regulatory actions and communications for safe use of marketed products.
DynaVet worked with FDA personnel to define the project and scope of work. The FDA OSE required DynaVet to update the Signal Detection and Signal Management Manual for these activities. There are ten (10) modules which required updating. Additionally, these modules had to be incorporated with four current background documents and modules and cross-referenced into a final, fully integrated Signal Detection and Signal Management manual. DynaVet is assisting the FDA to modernize the Regulatory Review Services across the various centers at the FDA and is providing medical technical writing, mobile application development, and other IT services.