Makary, Prasad set one pivotal trial policy via NEJM article – Endpoints News
- 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 firstwordpharma.com
- FDA will drop two-study requirement for new drug approvals, aiming to speed access AP News
- FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process The American Journal of Managed Care® (AJMC®)
- FDA leaders say one pivotal trial, not two, should be ‘default’ for drug approvals BioPharma Dive
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