FDA Division of Bioequivalence Director Dighe

Executive Summary

Detailed to Office of Generic Drugs Director Roger Williams, MD, as his "Senior Advisor with specific responsibility for development of a number of critically important bioequivalence guidances," a Dec. 3 OGD memo states. The detail takes effect Jan. 4 and will extend at least four months. Williams wants to have a senior employee work fulltime on the guidances to make them available sooner to industry. Shrikant Dighe, PhD, will focus on guidelines regarding albuterol metered-dose inhalers, cholestyramine, general bioequivalence, immediate-release formulations, controlled-release formulations and non-fasting drug bioequivalence. Review Branch I Chief Agnes Wu, PhD, will serve as the bioequivalence division's acting director.