FDA Will Begin End-Of-Phase IIa Meetings Prior To January Guidance
Executive Summary
FDA will begin a pilot program for end-of-Phase IIa meetings in advance of a draft guidance expected to be issued in early 2004
You may also be interested in...
FDA Puts Dose Selection At Top Of Agenda For End-Of-Phase 2A Meetings
Drug sponsors should use end-of-Phase 2A meetings for the in-depth discussions with FDA regarding dose estimation and selection that other pre-submission meetings do not allow for, according to a 1draft guidance
FDA Puts Dose Selection At Top Of Agenda For End-Of-Phase 2A Meetings
Drug sponsors should use end-of-Phase 2A meetings for the in-depth discussions with FDA regarding dose estimation and selection that other pre-submission meetings do not allow for, according to a 1draft guidance
Computer Simulations Of Clinical Trials To Be Addressed In FDA Guidance
FDA plans to address the use of computer simulation models in an upcoming guidance on issues firms should consider at the end of Phase IIa