fast track designation

What are the Benefits of Fast Track Designation?

Fast Track Designation offers several benefits, including:
More frequent meetings with FDA to discuss the drug’s development plan.
More frequent written communication from FDA about issues such as the design of proposed clinical trials.
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.
Rolling Review, which allows the drug company to submit completed sections of its New Drug Application (NDA) for review by the FDA, rather than waiting until every section is completed before the entire application can be reviewed.

Frequently asked queries:

What is Fast Track Designation?
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