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Pre-IND, End-Of-Phase II Meetings Can Decrease Development Time, FDA Says

Agency data indicate taking advantage of the early meetings with FDA officials can dramatically decrease mean clinical development times, especially for rare disease applications.

Stakeholders continue to look for ways to streamline drug development, but FDA has determined that using its existing formal meeting opportunities can drastically cut the time needed to complete development and get regulatory approval.

New molecular entity and novel biologic application sponsors that conducted pre-IND meetings with FDA saw shorter clinical development times. They also had more first-cycle approvals than “complete response” letters and...

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