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FDA (CDER)
GUIDANCE FINAL
M15 General Principles for Model-Informed Drug Development
Published: 6/2/2026Detected: 6/2/2026

Summary preview

Sets out general FDA principles for integrating model-informed approaches into drug development decisions across clinical, safety, quality, and labeling evidence packages.

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clinical
safety
manufacturing
labeling
quality
#model-informed drug development
#MIDD
#dose selection
#exposure-response
#clinical trial design

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