20080925 FDA DRAFT Guidance for Industry: End-of-Phase 2A Meetings

Guidance for Industry: End-of-Phase 2A Meetings [PDF] or [HTML]

INTRODUCTION
BACKGROUND
Strategies for Early Dose Selection
EOP2A Pilot Program
The EOP2A Meeting
Objectives of an EOP2A Meeting
EOP2A Meeting Requests
Useful Information for an EOP2A Meeting Package
EOP2A Meeting Arrangements
http://www.fda.gov/cder/guidance/8297dft.htm