Expedited Programs Shave Up to 2 Years Off Development/Review, JAMA Analysis Shows

September 5, 2023

FDA’s expedited regulatory programs cut up to two years off both clinical development and approval times for more than half of the drugs approved from 2015-2022, according to a new study.

Cancer and hematology drugs reaped the biggest benefit, with expedited programs shaving 1.2 years off the time from application to approval, and 1.4 years off the total time for both development and review to approval, Alissa K. Wong and colleagues wrote in JAMA Network Open.

Of the 367 therapeutics approved from 2015-2022, 57 percent employed at least one of the three FDA expedited programs: 118 (35 percent) used Fast Track, 109 (32 percent) Breakthrough, and 64 (19 percent) Accelerated Approval — some drugs obtain more than one designation.

Read the study here.

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