Issue Date: September 18, 2009
Issued by: Center for Drug Evaluation and Research
Topic(s): Administrative / Procedural
Status: Final
End-of-Phase 2A Meetings
This guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The purpose of an EOP2A meeting is to facilitate interaction between FDA and sponsors who seek guidance related to clinical trial design employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, placebo group responses, disease), designing trials for better dose response estimation and dose selection, and other related issues. This guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors.
Download the Guidance Document
