One-pivotal-trial rule aims to redefine drug approvals
TL;DR
FDA officials say a single pivotal trial will be the default standard for drug approvals, a policy shift outlined in an NEJM perspective by Marty Makary and Vinay Prasad.
- 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
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