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.

RegDesk is an A.I.-powered regulatory intelligence software that offers 24/7 access to the latest regulatory information for over 50 markets worldwide. Our platform eliminates the need for medical device companies to spend months gathering intelligence and preparing their registration applications. Through RegDesk’s centralized platform, clients can get access to product-specific registration requirements, expert answers to their most critical regulatory questions, and real-time alerts about global regulatory changes. To experience the power of RegDesk, contact us at desk@regdesk.co or visit www.regdesk.co.