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Interaction of the stakeholders and multilateral education at an early stage of development will facilitate drug development (e.g. ensuring outcome measures for clinical trials are developed that are meaningful for patients, are acceptable to the regulators, and are acceptable to payers)

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INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice on CBER products)

Published by IRDiRC

Early Access SupportScientific AdviceRegulatory AdviceTargeted Engagement for Regulatory AdviceDrug Development AdviceRegulatory Affairs

Through a CBER Initial Targeted Engagement for Regulatory Advice on CBER producTs (INTERACT) meeting, sponsors can obtain initial, nonbinding advice from FDA regarding chemistry, manufacturing and controls, pharmacology/Toxicology, and/or clinical aspects of the development program

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