Voldemort to streamline FDA clinical trials for new Drugs

Long overdue.

New HHS plan to streamline clinical trials

By Maya Goldman, Peter Sullivan and Tina Reed, Axios News · Jun 23, 2026

The Trump administration yesterday launched new efforts aimed at accelerating clinical trials that include allowing a single high-quality late-stage trial with supporting evidence to be sufficient for a drug approval.

Why it matters: The efforts come as China's biotech sector is threatening America's long-standing dominance in drug-making and biotech executives and investors are pressing the administration to respond.

Driving the news: The new steps include an FDA pilot program and updated guidance that the administration says could reduce early trial timelines by six to 12 months.

The agency also is continuing to pivot away from a requirement that two late-stage clinical trials be conducted for a drug approval.

NIH's National Cancer Institute will also take steps to improve enrollment in cancer studies. And the Office of the National Coordinator for Health Information Technology will look for ways to better connect patients with trials through electronic health records.

Context: Former FDA commissioner Marty Makary made a priority of revamping early-stage trials, but administration officials said the latest efforts have been under discussion since the beginning of Trump 2.0.