Model-Informed Drug Development Program Could Handle More Requests, But US FDA Needs Funding

FDA is considering allowing MIDD meeting requests to be submitted more often than the current quarterly schedule, but agency must have a plan to deal with the likely increased demand, official says.

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
  • Resources are limiting the FDA’s ability to increase the frequency of MIDD meeting requests.

The MIDD paired meeting program allows sponsors to meet with FDA staff to discuss exposure-based, biological, and statistical models derived...

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