- Makary, Prasad set one pivotal trial policy via NEJM article Endpoints News
- FDA’s new standard for approval will be for one pivotal trial, not two FirstWord Pharma
- It’s Official: FDA Will Now Default to One Clinical Trial for Drug Applications BioSpace
- FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process The American Journal of Managed Care® (AJMC®)
- FDA Moves Toward Faster Drug Approvals U.S. News & World Report
