FDA to hold three workshops on generic drugs

As part of an ongoing effort to bolster generic competition, FDA announced Tuesday three public workshops aimed at advancing development and review of new generic drugs.

The first workshop on Oct. 2-3 will discuss how quantitative approaches, such as model-informed drug development (MIDD) and simulation, can be used to improve product-specific guidance, ANDA reviews, and postmarket performance monitoring of generics. The meeting will also explore potential priority areas for global harmonization of the use of quantitative tools in regulatory decision-making...