LONG BEACH, CA – The model-informed drug development (MIDD) program at the US Food and Drug Administration could grow to better account for the realities of drug development, but likely would require additional resources, which industry already has questioned.
Key Takeaways
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Resources are limiting the FDA’s ability to increase the frequency of MIDD meeting requests.
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The quarterly request cycle does not fit with many sponsors’ schedules, causing them to ignore the program
The MIDD paired meeting program allows sponsors to meet with FDA staff to discuss exposure-based, biological, and statistical models derived from
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