RE:Accelerated Approval
ACCELERATED APPROVAL
For many medications, the effects and benefits take years to understand or appear. Taking that into account, the FDA has developed procedures to expedite the approval of these medications. The same year the FDA established the PDUFA, it instituted accelerated approval regulations. In 2021, 28% of approved drugs went through the Accelerated Approval pathway.
“These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. Using a surrogate endpoint enabled the FDA to approve these drugs faster,” stated the FDA website.
They define a surrogate endpoint as some measure that can predict or assume clinical benefit.