About Science & Research at FDA

The mission of the Food and Drug Administration (FDA) is the protection and advancement of public health by helping speed innovation on FDA regulated products.  To accomplish this, FDA makes risk assessment/risk management decisions on safety, efficacy, and quality of the products it regulates.  Evaluation of FDA regulated products requires application of the latest technology and standards pertinent to the particular regulatory challenges, e.g., in review of new products (drugs, biologics, medical devices or food additives) or in the resolution of compliance/safety issues of a marketed/regulated product.

Underlying FDA regulatory decisions are the application of advanced technology and science based standards.  Examples include the pre-market and post-market evaluation and approval of new technologies in the products, in addressing the many compliance issues that arise in the marketed products FDA regulates, and the use of new technologies in the manufacture and evaluation of innovative products.  The burden for FDA is to ensure the acceptance of our science-led regulatory decisions by the U.S. consumer and the respective scientific communities and thus maintaining scientific credibility, accuracy and predictability of the decision making process.

The objective of FDA research is to anticipate and resolve scientific and technical challenges before they become unsupported impediments, thus enabling the regulatory mission of FDA.  The applicability of this research for resolution of the many regulatory challenges and gaps is the common thread.  The foci on filling gaps unaddressed by traditional basic discovery research and resolving specific regulatory challenges are uniquely FDA.   FDA applies a unique combination of regulatory and scientific expertise in the research programs.  FDA research is translational, linking basic with applied research to address the pre-market or post-market concerns.  To bring additional relevance and value, the FDA serves as a leader, focusing collaborative research programs with other government agencies, industry, and academia.  FDA scientists bring regulatory relevance to the collaboration.

FDA scientists prioritize their agenda to the needs identified for efficient product development, using their regulatory expertise and in consultation with stakeholder, i.e., identifying, for example, the knowledge gaps that need to be filled to bring the new technology to the U.S. consumer.  Our scientists also provide the tools that the FDA inspection force needs to ensure that once the medical product has been approved, it is manufactured and marketed properly.  FDA research is the common pathway to enhance the success of NIH, United States Department of Agriculture (USDA), National Science Foundation (NSF), and other’s technology advances in public health by helping make their research directly relevant to determinations of safety and efficacy of new public health products.