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
View this resource Bookmark this resource
INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice on CBER products)
Published by IRDiRC
Regulatory AffairsEarly Access SupportScientific AdviceRegulatory AdviceTargeted Engagement for Regulatory AdviceDrug Development Advice