FDA and Personalized Medicine

| 01 March 2011

Regulatory Focus recently interviewed three US Food and Drug Administration (FDA) officials about the agency's perspective on personalized medicine. Following are excerpts from the interview with Lawrence J. Lesko, PhD, director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER); Elizabeth Mansfield, PhD, director for personalized medicine, Center for Devices and Radiological Health (CDRH); and Vicki Seyfert-Margolis, PhD, senior advisor for science innovation and policy, Office of the Commissioner.


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