Accelerated Approval Changes Likely in 2023

Included in — then stripped out of — user fee legislation in September were requirements that the FDA and drug manufacturers agree on post-approval study conditions prior to a drug’s accelerated approval (AA) and require more regular study progress updates from manufacturers. The proposals also sought to permit the FDA to require studies to be underway at the time the drug is approved, or prior to that time, and to allow use of real-world evidence to support the studies.
Source: Drug Industry Daily