The great thing about this announcement is that not only does it shorten timeframes, but it also significantly reduces the likelihood of unexpected delays or issues from the FDA as PAR has previously experienced, where you submit your data and information, only for a prolonged back and fourth Q&A over many months.
This shortens timeframes and massively reduces the risk of results not meeting FDA's requirements.
Ann: FDA Grants Paradigm Fast Track Designation For OA, page-88
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