The FDA expedites the review of drugs treating serious conditions with the potential to provide significant improvements in safety or effectiveness over existing therapies. Priority Review cuts the time in which the FDA aims to take action on a drug’s application from ten months to six.
Requirements:
- To be considered for Priority Review, a drug must address a serious condition and
- The drug must demonstrate, through clinical trial data or other scientifically valid information, the potential to provide a significant improvement in safety or effectiveness over existing treatments.
When to Submit a Request:
- Because Priority Review only impacts the marketing application review, which takes place late in the FDA approval process, drug sponsors generally submit requests either alongside or as a post-submission addition to a Biologics License Application (BLA) or New Drug Application (NDA).
Features:
- The FDA aims to take action on a drug sponsor’s marketing application in six months, compared with ten months for standard review.
Priority Review and Other Designations
- Accelerated Approval, Fast Track, and Breakthrough drugs can also be eligible for Priority Review.
The Perfect Candidate: Priority Review gives extra FDA attention to any drug with the strong potential to improve treatment of a serious disease. Drugs treating cancer, AIDS, Alzheimer’s, heart failure, Hepatitis C, diabetes, and many other serious diseases are frequently granted Priority Review.
