Mid-Phase III Meetings Suggested As Way To Increase First-Cycle Approvals
Executive Summary
FDA should consider conducting mid-Phase III meetings with drug sponsors as a way to improve the likelihood of approving an application during the first review cycle, a report by Booz Allen Hamilton recommends
You may also be interested in...
FDA Wants Promotional “Targets” From Sponsors Throughout Drug Development
Sponsors should provide FDA with proposed promotional claims at the beginning of the drug development process, the agency said in a draft guidance
FDA Wants Promotional “Targets” From Sponsors Throughout Drug Development
Sponsors should provide FDA with proposed promotional claims at the beginning of the drug development process, the agency said in a draft guidance
Past FDA Action Is Not Necessarily Predictive Of Future Behavior – Temple
Sponsors should not assume clinical trials are immune from evaluation according to updated efficacy standards, even if parameters are initially agreed upon with the agency