Drug Fix: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss the reasons Iilun Murphy, director of the US Food and Drug Administration’s Office of Generic Drugs, decided to step down (:53) and whether the move should concern senior agency officials (2:51). They also consider the FDA’s plan to create a fit-for-purpose rare disease approval framework (12:19), how it will connect with the agency’s litany of programs for the products (14:52) and the potential difficulties of systematizing regulatory flexibility (18:22).

More On These Topics From The Pink Sheet

US FDA Generic Drugs Office Director Steps Down Amid ‘Political Pressure,’ Admin Burden: insights.citeline.com/pink-sheet/biosimilars-a…

US FDA’s Rare Disease Framework Envisions Systematic Regulatory Flexibility: insights.citeline.com/pink-sheet/rare-diseases…

US FDA Eyes Adaptive Rare Disease Framework To Replace Piecemeal Flexibilities: insights.citeline.com/pink-sheet/rare-diseases…