Back to today’s briefing

Story perspectives

FDA Streamlines Drug Approvals with Single Trial Requirement

2/23/2026

44 3 Full Breakdown

Summary

Story summary

The FDA will require only one pivotal trial for drug approvals, instead of two, to reduce costs and speed therapy access.
Commissioner Marty Makary announced the change and said the FDA will maintain rigorous standards.
Makary has implemented AI tools to streamline reviews and launched a pilot for expedited drug approvals.
The approach aligns with Trump administration efforts to cut regulatory burdens and spur economic growth.

1 of 1

Story summary

The FDA will require only one pivotal trial for drug approvals, instead of two, to reduce costs and speed therapy access.
Commissioner Marty Makary announced the change and said the FDA will maintain rigorous standards.
Makary has implemented AI tools to streamline reviews and launched a pilot for expedited drug approvals.
The approach aligns with Trump administration efforts to cut regulatory burdens and spur economic growth.