Comment from IQ Consortium & IQ Microphysiological Systems Affiliate
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Summary: The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) submitted comments supporting the draft guidance on New Approach Methodologies (NAMs) in drug development. They provide specific technical recommendations to clarify definitions, emphasize the "fit-for-purpose" principle over mandatory validation, and request more detail on in silico methods and human biological relevance.
We are pleased to offer the following comments, developed with the support of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ, www.iqconsortium.org). IQ is a not-for-profit organization of pharmaceutical and biotechnology companies with a mission of advancing science and technology to augment the capability of member companies to develop transformational solutions that benefit patients, regulators and the broader research and development community.
IQ’s MPS Affiliate, IQ 3Rs TPS and IQ DruSafe Leadership Group appreciate the opportunity to review the draft guidance and share our feedback. Specific concerns and feedback on the draft guidance follow.