Drug Fix: US FDA’s New Guidance On One-Trial Efficacy Standard And IND Reform Pilot

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs discuss the potential impact of the US Food and Drug Administration’s new updated guidance describing the one-trial plus confirmatory evidence standard for effectiveness (:47) and the significance of advancing yet another priority of former Commissioner Martin Makary (6:47). They also talk about the details of the agency’s planned pilot program to streamline IND clearances, including questions about the program’s feasibility. (14:08). More On These Topics From The Pink Sheet US FDA Rewrites Effectiveness Playbook, Positions Single-Pivotal-Trial Pathway As New Normal: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-rewrites-effectiveness-playbook-positions-single-pivotal-trial-pathway-as-new-normal-XUVWF3SKQNANDMY4IW5SXTJZYE/ US FDA IND Reform Pilot Would Let ‘Qualified’ Outside Institutions Give Advice To Speed Approval: https://insights.citeline.com/pink-sheet/r-and-d/clinical-trials/us-fda-ind-reform-pilot-would-let-qualified-outside-institutions-give-advice-to-speed-approval-RIPFHRJUERCULKXWCQMXW3PX3M/