Recommendations for improving quality of bioequivalence data submitted to ANDAs in US

Dr. Barbara M. Davit
Director, Division of Bioequivalency II, Center for Drug Evaluation and Research, FDA, Rockville, Maryland, USA

Barbara Davit, Ph.D., J.D., is Director of the Division of Bioequivalence II in the Office of Generic Drugs (OGD), CDER/FDA. She supervises a staff of 40 scientists and pharmacists, who are responsible for reviewing bioequivalence data in Abbreviated New Drug Applications for generic versions of antiviral, antibiotic, anti-inflammatory, anti-convulsant, analgesic, cardiovascular, transplant, and locally-acting GI drugs. Dr. Davit holds a B.S. in Chemistry from Georgian Court College, a Ph.D. in Nutrition Science with minors in Biochemistry/Statistics from the University of California, Davis, and a J.D. from George Mason University School of Law. Dr. Davit trained in pharmacokinetics as a fellow at the California Primate Research Center. Following several years in the CRO industry, she joined CDER/FDA as a Reviewer in 1991. Within OGD, she served as Team Leader from 1998-2003 and as Deputy Director from 2003-2008. She is the lead OGD clinical pharmacologist for implementing tentative approvals of generic anti-retroviral drugs under the President’s Emergency Plan for AIDs Relief (PEPFAR). Dr. Davit develops CDER biopharmaceutic and generic drug guidances, leads bioequivalence research projects within her division, and provides technical assistance to FDA counsel as needed. She has co-authored numerous book chapters and original research articles on bioequivalence testing of generic drug products, and has given over 100 invited national and international oral and poster presentations throughout her career.