FDA published a Federal Register notice entitled, “Pilot Meetings Program for Model-Informed Drug Development Approaches.” MIDD approaches use a variety of quantitative methods to help balance the risks and benefits of drug products in development and when successfully applied, can improve clinical trial efficiency, increase the probability of regulatory success, and optimize drug dosing/therapeutic individualization in the absence of dedicated trials. The pilot program provides sponsors or applicants who are selected to participate the opportunity to meet with Agency staff to discuss MIDD approaches in medical product development.
The program period will run from fiscal years 2018 to 2022. FDA subject matter experts from relevant fields such as clinical pharmacology will lead the meetings. Experts from the Center for Drug Evaluation and Research (CDER) and/or Center for Biologics Evaluation and Research (CBER) will participate as needed. The pilot program is being conducted to fulfill a performance goal under PDUFA VI, incorporated as part of the FDA Reauthorization Act of 2017. Under the pilot, FDA has committed to accepting 2-4 paired-meeting requests quarterly each fiscal year.
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