About Science & Research at FDA

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Headline News

Broad Agency Announcement: FDA Solicits for R&D
to Support Regulatory Science and Innovation

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FDA's misson is to protect and advance public health by helping speed innovation with respect to FDA-regulated products.  The Agency achieves this by making risk assessment and risk management decisions on the safety, efficacy, and quality of our products.  During the evaluation process, FDA is required to apply the latest technology and standards relevant to the specific regulatory challenges these products present, for example, in reviewing drugs, biologics, medical devices or food additives, or in resolving their compliance/safety issues.

 

The application of advanced technology and science-based standards underlies all FDA regulatory decisions.  These decisions involve pre-market and post-market evaluation and approval of new technologies in FDA's regulated products, addressing the many compliance issues that arise as well as the use of new technologies in the manufacture and evaluation of innovative products.  FDA's responsibility is to ensure that the U.S. consumer and the respective scientific communities accept our science-led regulatory decisions and hence that we maintain scientific credibility, accuracy, and predictability of the decision-making process.

FDA's research goal is to anticipate and solve scientific and technical challenges before they become obstacles to our regulatory mission.  The application of this research to figure out these many regulatory challenges is the common thread woven throughout all FDA's work.  FDA's unique role is to close the gaps that basic discovery research has not addressed and successfully tackle specific regulatory challenges.   FDA applies a unique combination of regulatory and scientific expertise in its research programs.  FDA research is translational, linking basic with applied research to address pre-market or post-market concerns.  FDA serves as a leader in bringing regulatory relevance to collaborative research programs with other government agencies, industry, and academia.

FDA scientists prioritize their agenda to the needs identified for efficient product development, using their regulatory expertise and--in consultation with stakeholders--identifying, the knowledge gaps that must be addressed to bring new products to the U.S. consumer.  Our scientists also provide the tools that the FDA inspection force needs to ensure that once a medical product has been approved, it is manufactured and marketed properly.  FDA research provides the common pathway through which the success of NIH, the U.S. Department of Agriculture (USDA), the National Science Foundation (NSF), and other technology advances in public health are enhanced by helping make their research directly relevant to determinations of safety and efficacy of new public health products.