Drug Fix: The New Acting US FDA Biologics Center Director, SCOTUS Eyes Generic Drug Policy

Pink Sheet Executive Editor Derrick Gingery, Senior Reporter Maaisha Osman, Senior Editor Sue Sutter, Editor-in-Chief Nielsen Hobbs and Generics Bulletin Executive Editor Dave Wallace discuss US Food and Drug Administration Commissioner Martin Makary’s appointment of Katherine Szarama as acting Center for Biologics Evaluation and Research director and the updated timeline for find a permanent director (:33), as well as and Makary’s approach compared to the recent Center for Drug Evaluation and Research leadership change (4:39). They also consider the impact of the US Supreme Court’s review of the generic drug skinny label policy (10:54). #pharma #business More On These Topics From The Pink Sheet Alternate Leadership Strategy: Deputy Director Szarama Is Acting US FDA Biologics Center Chief: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/alternate-leadership-strategy-deputy-director-szarama-is-acting-us-fda-biologics-center-chief-P6ZJLJY7YBDUXCG6DMWNYNIHUI/ US FDA’s Makary Expects To Name Permanent CBER Director Within Weeks As Prasad Departs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fdas-makary-expects-to-name-permanent-cber-director-within-weeks-as-prasad-departs-37ZOLQT6FNDARGPMZOE2EI2DPE/ Skinny Label At SCOTUS: Could Generics Maintain Carve-Out Authority No Matter The Decision?: ⁠https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/skinny-label-at-scotus-could-generics-maintain-carve-out-authority-no-matter-the-decision-54CTMA7XSBGIFF7WOYPGA26PGM/