Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Expedited Review Programs Not Shortening Drug Development

Key clinical point: Overall drug development times steady despite shorter review times.

Major finding: Even with most new drug approvals getting expedited review, total development time remains consistent.

Study details: Researchers looked at FDA databases of approved new drugs, approved generics, approved biologics, and approved vaccines as well as various programs at the agency designed to speed up the approval process.

Disclosures: The research was supported by Arnold Ventures and grants from the Harvard–MIT Center for Regulatory Science and the Engelberg Foundation. No conflicts of interest were reported by the authors.


Darrow J et al. JAMA 2020 Jan 14. doi:10.1001/jama.2019.20288.