Published in Medical Letter on the CDC and FDA, April 6th, 2003
Priority Review is granted by the FDA to an NDA for a new treatment that addresses an unmet medical need. The FDA expedites the approval process for such an NDA by reducing the target review period for the application from 10 months to 6 months. Acceptance of the filing means that FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive...
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