Drug Fix: US FDA’s Makary Pressured To Resign, Continues Hiring, Reform Efforts
Pink Sheet Executive Editor Derrick Gingery, Senior
Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the increasing pressure on US Food and Drug Administration Commissioner Martin Makary to resign and its long-term impact on the agency (:34). They also discuss Makary’s comments on patient anecdotes influencing regulatory decisions on psychedelic drugs and his new AI-enabled one-day facility inspection program (12:14), criticism of Makary’s Commissioner’s National Priority Voucher Program (18:49), and his intent to hire 3,000 new scientists (23:12).
#pharma #business
More On These Topics From The Pink Sheet
Psychedelic Testimonials Alone Cannot Meet Legal Approval Standard, US FDA’s Makary Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/psychedelic-testimonials-alone-cannot-meet-legal-approval-standard-us-fdas-makary-says-OCRVXBPRMJAR3I5LCSA7QER724/
US FDA Piloting AI-Enabled One-Day Inspections To Expand Oversight, Improve Efficiency: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-piloting-ai-enabled-one-day-inspections-to-expand-oversight-improve-efficiency-ULUXK3SYFVF4ZDHYTA4QWXNDJE/
US FDA Hiring 3,000 Scientists To Power Sweeping Reform Agenda, Makary Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-hiring-3000-scientists-to-power-sweeping-reform-agenda-makary-says-HCDJTHZFUFBSZL5C2DKCG7FPAE/
US FDA Limits Some Staff Performance Awards, In Part Because Funds Are Insufficient: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-limits-some-staff-performance-awards-in-part-because-funds-are-insufficient-YMV4DDERO5A5LO5AOSORPXWDGE/
Reporter Maaisha Osman and Editor-in-Chief Nielsen Hobbs consider the increasing pressure on US Food and Drug Administration Commissioner Martin Makary to resign and its long-term impact on the agency (:34). They also discuss Makary’s comments on patient anecdotes influencing regulatory decisions on psychedelic drugs and his new AI-enabled one-day facility inspection program (12:14), criticism of Makary’s Commissioner’s National Priority Voucher Program (18:49), and his intent to hire 3,000 new scientists (23:12).
#pharma #business
More On These Topics From The Pink Sheet
Psychedelic Testimonials Alone Cannot Meet Legal Approval Standard, US FDA’s Makary Says: https://insights.citeline.com/pink-sheet/pathways-and-standards/approval-standards/psychedelic-testimonials-alone-cannot-meet-legal-approval-standard-us-fdas-makary-says-OCRVXBPRMJAR3I5LCSA7QER724/
US FDA Piloting AI-Enabled One-Day Inspections To Expand Oversight, Improve Efficiency: https://insights.citeline.com/pink-sheet/compliance/manufacturing/us-fda-piloting-ai-enabled-one-day-inspections-to-expand-oversight-improve-efficiency-ULUXK3SYFVF4ZDHYTA4QWXNDJE/
US FDA Hiring 3,000 Scientists To Power Sweeping Reform Agenda, Makary Says: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-hiring-3000-scientists-to-power-sweeping-reform-agenda-makary-says-HCDJTHZFUFBSZL5C2DKCG7FPAE/
US FDA Limits Some Staff Performance Awards, In Part Because Funds Are Insufficient: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-limits-some-staff-performance-awards-in-part-because-funds-are-insufficient-YMV4DDERO5A5LO5AOSORPXWDGE/
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