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.


  • 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:


  • 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

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.