Pink Sheet Executive Editor Derrick Gingery, senior writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor in Chief Nielsen Hobbs consider whether new biosimilar promotion guidance could be a step toward administratively eliminating the interchangeability designation (:34), the impact of upcoming accelerated approval guidance on gene therapy development (14:15), and whether a recent spate of partisan attacks that US Food and Drug Administration Commissioner Robert Califf had to endure represents a shift in attitude toward the agency (27:13).
More On These Topics From The Pink Sheet
- Rx Advertising: Interchangeability Doesn’t Mean Clinical Superiority To Other Biosimilars, FDA Says
- US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
- Partisan Politics Returns To US FDA Congressional Oversight
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