FDA Puts Dose Selection At Top Of Agenda For End-Of-Phase 2A Meetings
Executive Summary
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
You may also be interested in...
EOP2A Guidance Allows That Resource Constraints Might Block Meetings
FDA's final guidance on end-of-Phase 2A meetings codifies into policy the more realistic expectations of what the agency can handle in terms of meeting requests.
EOP2A Guidance Allows That Resource Constraints Might Block Meetings
FDA's final guidance on end-of-Phase 2A meetings codifies into policy the more realistic expectations of what the agency can handle in terms of meeting requests.
Health Care and the 2008 Election: Revolution, Reform, or Return to Business as Usual?
As the presidential race heats up, health care executives say they have many reasons to be excited--and nervous. BCG reviews an industry-wide survey on the implications of the candidates' health care proposals for the pharma and device industries.