Feb. 6 at 5:44 PM
$VRTX $AUPH $ACAD To cut down on these burdens, FDA Commissioner Marty Makary told Stat on Dec. 4 the agency would change default requirements in Phase 3 clinical trials from two pivotal trials to one. While some drugs, depending on what they treat, will still require two trials, the goal is to make drug development more efficient.
This rule continues previous FDA initiatives to ease the process, such as when the agency announced it would allow one trial with confirmatory evidence before approval in 2023.
Biotech experts told Healthcare Brew this rule change could help bring drugs to market, but it’s also not a one-size-fits-all solution.
“The devil is going to be details because at the end of the day Congress requires the FDA to ensure the safety and efficacy of drugs that go into human beings,” Rahul Gupta, president of tech company GATC Health, told us.
https://www.healthcare-brew.com/stories/2026/02/04/biotechs-save-time-money-clinical-trial-rule-change?mbcid=43933921.130192&mblid=074aa09ef76f&mid=8764486d5a0c8dedd5ecf7f1eafe54d7&utm_campaign=hcb&utm_medium=newsletter&utm_source=morning_brew
