Background:The significance of expedited programs has grown for new drugs that address severe diseases, especially those that provide the first treatment options or meet unmet medical needs. To facilitate quicker availability, the FDA has established distinct programs like the Fast Track and Breakthrough Therapy designations.Purpose:This research aims to explore the overall trends regarding the Fast Track and Breakthrough Therapy designations for new drugs. The study examines the status of these designations and analyzes the approval timelines for drugs that received either of these expedited designations, particularly in relation to the Priority Review designation.Method:The study covered the past 10 years, from 2013 to 2022, as the FDA introduced the Breakthrough Therapy designation in 2012, with the first drug being approved under this program in 2013. The analysis focused on the number of new drugs designated Fast Track or Breakthrough Therapy, and the proportion of these drugs that received Priority Review. The time taken for approval was calculated using the Drugs@FDA database.Result:Over the past decade, the FDA approved 428 new drugs. Of these, 155 were Fast Track and 122 were Breakthrough Therapy designated. Most of these drugs received the Priority Review designation, indicating a statistically significant correlation between receiving either of the expedited designations and Priority Review (p < 0.05). Drugs designated Fast Track or Breakthrough Therapy took nearly the same time to be approved as those that received Priority Review, averaging 8 months.Conclusion:The study found that over 90% of the Fast Track or Breakthrough Therapy designated drugs received Priority Review. Additionally, these drugs typically took about 8 months for approval. Future efforts should focus on publicly disclosing the FDA’s reasons for granting or denying expedited program designations, as this transparency could accelerate the development of new drugs.