FDA drug approvals: Makary and Prasad say one study will be enough

Main Idea: FDA leaders Dr. Marty Makary and Dr. Vinay Prasad say the agency will usually require only one strong study to approve new drugs, replacing its long-standing two-study standard.

Key Points:

• The FDA says its new “default position” will be one study for new drugs and other novel health products.
• Makary and Prasad say modern drug research is precise enough that a second trial is often no longer needed.
• The change is meant to speed up approvals and reduce red tape, and the FDA says it could boost drug development.
• Experts say the new rule will mostly affect medicines for common diseases, since rare and life-threatening conditions already often use single-trial approvals.