Priority Review

Priority review establishes a target of 6 months for FDA review of a drug product that "would be a significant improvement compared to marketed products in the treatment, diagnosis, or prevention of a disease." Designation of a priority review for a biologic product is stricter in that treatment must be for a "serious or life-threatening disease." A sponsor must request and justify a priority review at the time they make a submission for a drug or biologic approval. If priority review is not granted, the targeted FDA review time for a standard review is 10-12 months. Thus, a priority review provides an opportunity to have a product on the market 4-6 months earlier than a product with a standard review.

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