Drugs

Model-Informed Drug Development Comments

Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA taking steps to increase the use of model-informed drug development (MIDD) approaches in regulatory decision-making, to understand how sponsors are using emerging MIDD approaches within medical product development, and to enhance interactions with sponsors regarding MIDD. Responding to an agency request for information, PhRMA says MIDD “is a critical component of enhancing clinical trial innovation” and the association supports agency efforts to develop new guidances and policies to advance MIDD.

“We encourage the agency to ensure that any updated or new guidance or policies allow for adequate flexibility to maximize the full benefits of MIDD approaches,” PhRMA says.

In its response, Parexel provides considerations and recommendations for dose selection optimization, first-in-human studies, bioequivalence assessment, artificial intelligence/machine learning, and the MIDD program.

The American Society for Clinical Pharmacology & Therapeutics offers specific recommendations for reducing barriers in uptake, supporting content and access in MIDD knowledge and tools, and providing clarity on regulatory assessment and acceptance.

Finally, the Critical Path Institute response identifies areas where further clarification would improve the guidance’s usefulness in terms of context-specific considerations and regulatory engagement.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome