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FDA Launches General Principles of Model-Integrated Evidence (MIE) Industry Meeting Pilot for Generic Drug Applicants

U.S. FDA launches a groundbreaking pilot program for the pharmaceutical industry! The program is known as the “General Principles of Model-integrated Evidence (MIE) Industry Meeting Pilot”

The FDA is taking a giant leap forward in fostering digital innovation and collaboration within the generic drug development space. They have introduced the MIE Industry Meeting Pilot program to facilitate early and focused interactions between FDA experts and generic drug applicants who plan to use in silico. 

U.S. FDA launches a groundbreaking pilot program for the pharmaceutical industry! The program is known as the “General Principles of Model-integrated Evidence (MIE) Industry Meeting Pilot”

The primary goal of this pilot program is to enhance scientific communication and in silico collaboration between generic drug developers and the FDA. The program seeks to leverage cutting-edge quantitative methods, AI/ML, and modeling & simulation techniques to address complex issues in generic drug development that cannot be efficiently tackled through existing channels. 

Program Objectives:
  • Optimize Modeling Approaches: Evaluate if and/or how the proposed modeling approaches can be used in a specific drug development program. 
  • Advance Modeling Method: Improve modeling methodologies to address common issues with multiple products from the same applicant. 
  • Implement Innovative Approaches: Implement innovative approaches in the development of non-complex products, areas often overlooked in existing meetings. 

Priority focus areas to optimize time and resources of the pilot program are:
  • Innovative MIE-focused approaches for BE establishment that cannot be effectively addressed under the existing GDUFA scientific meetings 
  • Non-complex products with complex approaches/modeling 
  • Novel data analytics tools and approaches (e.g., machine learning and artificial  intelligence) for BE establishment and assessment 

This program promises to revolutionize the drug development landscape by fostering closer collaboration between industry players and regulatory authorities. It’s an exciting step towards wider adoption of in silico and more efficient and innovative generic drug development. 

Stay tuned to our blog for more regulatory updates and connect with us at InSilicoMinds to learn how we can help execute your in silico requirements!

Keywords: FDA, Drug Development, In Silico, Pharmaceutical Industry, Artificial Intelligence, Machine Learning,

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