Six tips for making the most of your FDA INTERACT meeting

Although all FDA meetings play a critical role in any sponsor’s development strategy, when it comes to cell and gene therapies, the most valuable FDA interaction is arguably the very first: the INTERACT meeting. During the INTERACT meeting, sponsors can obtain initial, nonbinding advice from FDA regarding chemistry, manufacturing and controls (CMCs); pharmacology and toxicology; and the clinical aspects of their development program. This informal meeting should take place prior to any pivotal nonclinical studies, but after the sponsor has a good understanding of the manufacturing process. If managed wisely and well prepared for, the INTERACT meeting can prove invaluable in gaining early input from FDA regarding the evidence and detail needed to understand and evaluate the risk-benefit profile of your specific therapy. And that feedback is essential to de-risking and accelerating the development process.

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