Zdrowie i gospodarka · 26/09/2008

FDA Releases Draft Guidance for Industry on End-of-Phase 2A Meetings

The Food and Drug Administration (FDA) has released a draft guidance for industry on end-of-phase 2A meetings, which aims to help sponsors of investigational new drug applications (INDs) design trials using clinical trial simulation and quantitative modeling. The guidance is part of the FDA's efforts to improve the quality of drug applications through early meetings with sponsors.