Drug Regulators, FDA CDER, Publish Guidance on End-of-Phase 2a Meetings
This guidance provides information on end-of-phase 2A (EOP2A) meetings for sponsors of investigational new drug applications (INDs). The purpose of an EOP2A meeting is to facilitate interaction between FDA and sponsors who seek guidance related to clinical trial design employing clinical trial simulation and quantitative modeling of prior knowledge (e.g., drug, placebo group responses, disease), designing trials for better dose response estimation and dose selection, and other related issues. This guidance is intended to further FDA initiatives directed at identifying opportunities to facilitate the development of innovative medical products and improve the quality of drug applications through early meetings with sponsors.
An EOP2A meeting would occur after the completion of clinical trials that provide data on the relationship of dosing and response for the particular intended use (including trials on the impact of dose ranging on safety, biomarkers, and proof of concept). For the purposes of this guidance, end of phase 2A occurs after the completion of phase 1 trials and the first set of exposure-response trials in patients, and before beginning phase 2B (i.e., patient dose-ranging trial) and phase 3 clinical efficacy-safety trials. In the context of drug development programs, discussions at an EOP2A meeting could include exploration of dose estimation and dose selection to use in late stage efficacy trials. Where novel trial designs are a possibility, their utility and applicability could be discussed at an EOP2A meeting.
This guidance focuses on the following specific topics:
● Objectives of the EOP2A meeting
● Considerations for evaluating EOP2A meeting requests
● Useful information for an EOP2A meeting package
● EOP2A meeting arrangements
If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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