A Priority Review designation means the FDA’s goal is to act on an application within 6 months of filing by the FDA. A drug, including those that received Fast Track, Breakthrough Therapy, or RMAT designation, may be eligible for Priority Review, if it meets the criteria for Priority Review at the time the marketing application is submitted. A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. [9]
At the time of a pre-biologics license application (pre-BLA) meeting with CBER, sponsors of regenerative medicine therapies, including those under expedited development programs, should consider discussing their eligibility for Priority Review. A regenerative medicine therapy may receive Priority Review if it treats a serious condition, and, if approved, would provide a significant improvement in the safety or effectiveness of the treatment of the condition.