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>>1361
FDA will accept two to four paired meeting requests quarterly each year through June 15, 2022, with an initial focus on dose selection, clinical trial simulation and predictive or mechanistic safety evaluation.
The agency held a joint workshop in February with the International Society of Pharmacometrics to discuss MIDD for oncology products, as models can support dosing decisions and help companies make faster, better decisions about which products and combinations to take forward. FDA officials championed MIDD as a means to determine the optimal use of new products when scant clinical data leave unanswered questions.
One way companies and FDA are using MIDD is to model the phenomena that explain how tumor sizes and rates of growth change over time. This modeling of tumor kinetics gives more information about how tumors respond to treatments than RECIST criteria. As a result, these models can allow companies and regulators to draw more conclusions from their data.