Each drug marketed in the United States must go through a review process that is facilitated by the FDA. The Prescription Drug User Act (PDUFA) better facilitates faster drug review times as a two-tiered system, which includes standard review and priority review.
Here are some key points:
1. For priority review, The FDA will review the application within 6 months, in contrast with the standard which takes 10 months.
2. Attention and resources are directed to the evaluation of these priority drug applications which play a large role in the increased safety and efficacy of the treatment when compared to standard applications.
3. The review designation is decided by the FDA. Although, an applicant can request the desire for priority review as per instructions by the Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics.
4. Priority review does not affect clinical trial period time, the standard for approval either scientifically or medically, and the quality of the evidence that needs to be provided for a drug to be approved.
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