Feb. 19 at 1:27 PM
$KURA
- FDA will drop two-study requirement for new drug approvals, aiming to speed access.
- Going forward, the FDA’s “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a New England Journal of Medicine piece published Wednesday February 18, 2026.