The FDA Guidance on End-of-Phase 2A Meetings (EOP2A) has now been published in the federal register after a one year public comment period. EOP2A meetings are implemented to facilitate interaction between the FDA and sponsors who seek guidance related to clinical trial design especially when it comes to possibilities to improve dose selection like for example:
Like the sponsors, the FDA has a high interest in defining dose or exposure-response relationships for the effectiveness and safety of new drugs as dose selection for phase 2 and phase 3 studies is a challenge in many drug development programmes. A wrong choice might even lead to a failure of the trial. But a trial planning might be improved by clinical trial simulations that employ quantitative models of drug-exposure response, placebo effect and disease progression.
In response to the public comments, a few topics have now been clarified on the type of information to be submitted and the role of the Office of New Drugs. Although the public comment period is over, interested persons may still submit written or electronic comments regarding this document.
The final guidance focuses on the following specific topics:
The Guidance does not discuss the general procedures for requesting, scheduling, conducting, and documenting formal meetings. For general information on those topics, see the guidance for industry on Formal Meetings with Sponsors and Applicants for PDUFA Products (the Formal Meetings guidance).
On the behalf of the European Compliance Academy (ECA)