One-Study Path to FDA Drug Approvals Sparks Policy Debate
TL;DR
FDA Commissioner Marty Makary and Prasad argue that a single pivotal study could suffice for drug approvals, a shift aimed at speeding access but drawing concerns about the robustness of evidence and patient safety.
- FDA will drop two-study requirement for new drug approvals, aiming to speed access Associated Press News
- ‘Just Agree to It:’ Pazdur Said He Was Told To Cosign FDA’s Reduced Trial Requirements BioSpace
- Experts react to FDA’s shift to single pivotal trials for most drugs Regulatory Affairs Professionals Society | RAPS
- FDA Policy Shift: Impact on AstraZeneca (AZN) and Pharmaceuticals GuruFocus
- FDA to begin requiring on clinical trial TipRanks
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