FDA to require one study for new drug approvals to speed patient access

The FDA will eliminate the requirement for two studies for new drug approvals, aiming to speed patient access. This change, announced by FDA Commissioner Dr. Marty Makary, will make one study the default for novel health products, reflecting advancements in research precision. The two-study standard, in place since the 1960s, is being updated to accelerate drug development for common diseases, building on existing single-study approvals for rare conditions.