LEAD PHARMACOLOGIST
US Food and Drug Administration
Fang Lu, Ph.D.,
As a Lead Pharmacologist within the Office of Bioequivalence, Office of Generic Drugs, CDER, U.S. Food and Drug Administration, providing authoritative pharmacology and regulatory guidance for the assessment of Abbreviated New Drug Applications (ANDAs) and Investigational New Drug Applications (INDs), with an emphasis on in vivo and in vitro bioequivalence evaluation of generic drugs; evaluating the pharmacological and toxicological data including clinical and non-clinical evaluations of the efficacy and the safety seen in bioequivalence studies pertaining to Bio-INDs, ANDAs, amendments and supplements; in supporting the reviews of the ANDAs and INDs, further cross referencing and re-evaluating the results and reports from the New Drug Applications (NDAs); assessing bioequivalence protocols and control correspondences and providing recommendations on in vivo and in vitro bioequivalence studies; providing expertise advice in interpreting FDA regulations and guidelines pertaining to evaluate the safe and effective use of generic drugs to other disciplines of FDA and responding to the consults and inquiries from industry representatives by teleconference or in writing.