FDA Dropping Requirement for 2 Studies for New Drug Approvals

‘A one-trial requirement will be the FDA’s new default standard,’ agency leaders said.

FDA Commissioner Dr. Marty Makary in Washington on July 29, 2025. Saul Loeb/AFP via Getty Images

The Food and Drug Administration will approve many new drugs based on one trial moving forward, agency leaders have said.

The FDA has typically required two studies from companies seeking approval for most new drugs, although in recent years it has approved some drugs based on a single well-run trial.