Pink Sheet Podcast: Rare Pediatric Disease PRV Deadline, Potential Makena Compounding Ban
Executive Summary
Pink Sheet reporter and editors discuss the potential fallout if the US FDA’s rare pediatric disease priority review voucher program is allowed to sunset, as well as an upcoming agency advisory committee meeting on potentially banning compounding of the active ingredient in the now-withdrawn pre-term birth prevention drug Makena.
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Interim Editor-in-Chief Nielsen Hobbs consider the ramifications of ending the rare pediatric disease priority review voucher program, should Congress not renew it by the 1 October deadline (:30). They also discuss an upcoming advisory committee meeting and potential US Food and Drug Administration decision on banning compounding of the active ingredient in Covis Pharma’s preterm birth medication Makena (hydroxyprogesterone caproate), which was withdrawn from the market in 2023 (18:39).
More On These Topics From The Pink Sheet
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US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization
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Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal
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US FDA Panel To Consider Compounding Ban For Makena’s Active Ingredient
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