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Richard A. Forshee, PhD

Deputy Director
Office of Biostatistics and Pharmacovigilance, CBER, US FDA
Silver Spring, United States


Richard Forshee is the Deputy Director of the Office for Biostatistics and Pharmacovigilance at FDA/CBER. He has more than 25 years of experience as a researcher and leader in academia and the Food and Drug Administration. He joined FDA full time in 2008 after working for more than a decade in academia. At FDA, he led the Analytics and Benefit-Risk Assessment Team for the Office of Biostatistics and Pharmacovigilance (OBPV) in CBER and worked extensively to provide quantitative benefit-risk assessment and real-world evidence to ensure the safety and efficacy of biologic products. This work supports OBPV’s review, regulatory, and public health missions. Dr. Forshee provides knowledge and expertise on scientific and regulatory matters at Center, Agency, US government, and international meetings, workshops, and conferences.

Dr. Forshee has won numerous awards including the FDA Award of Merit, the FDA-CBER Award for Managerial Excellence, and the CBER Hope Hopps Memorial Award. In 2020, he was awarded the Society for Risk Analysis Outstanding Practitioner Award. He has published more than 120 scientific articles which have been cited more than 5,800 times.

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