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Drug Fix: US FDA Drops Offit, Others From Adcomms, Releases Unapproved Product Rejection Letters

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Manage episode 504680417 series 2877522
Content provided by Citeline. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Citeline or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47). More On These Topics From The Pink Sheet Offit’s VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ US FDA Compounding Advisory Panel Hit Hardest By Recent Purges: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-compounding-advisory-panel-hit-hardest-by-recent-purges-OXBD4IXGFZCIDIMB6VXSOSVP6U/ 89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/89-complete-response-letters-one-huge-leap-for-us-fda-transparency-for-unapproved-drugs-SLYA5LADMNDY3LKZ5TRUAWRRAU/
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1578 episodes

Artwork
iconShare
 
Manage episode 504680417 series 2877522
Content provided by Citeline. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Citeline or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://podcastplayer.com/legal.
Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47). More On These Topics From The Pink Sheet Offit’s VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ US FDA Compounding Advisory Panel Hit Hardest By Recent Purges: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-compounding-advisory-panel-hit-hardest-by-recent-purges-OXBD4IXGFZCIDIMB6VXSOSVP6U/ 89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/89-complete-response-letters-one-huge-leap-for-us-fda-transparency-for-unapproved-drugs-SLYA5LADMNDY3LKZ5TRUAWRRAU/
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