Drug Fix: Another FDA Inspection Reorg, Industry Navigating New DTC Landscape
Update: 2025-10-24
Description
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs explain the reasons for the US Food and Drug Administration’s planned “Simple Reform” of its inspection group, including the move away from specialized teams (:44). They also consider industry’s current thinking on best practices for navigating the agency’s new position on direct-to-consumer ad regulation (18:45 ).
More On These Topics From The Pink Sheet
US FDA Plans Move Back To More Generalist Inspectorate: https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M/
Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/industry-rethinking-visual-elements-and-quality-of-life-claims-after-us-fda-drug-ad-crackdown-WMXPANFVC5B55GZZQ6IWJG4FRE/
US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-adpromo-crackdown-letters-came-from-opdp-staff-not-artificial-intelligence-RKTSXQ5ZV5BPJD4DXGAOS5SS5Q/
More On These Topics From The Pink Sheet
US FDA Plans Move Back To More Generalist Inspectorate: https://insights.citeline.com/pink-sheet/compliance/us-fda-plans-move-back-to-more-generalist-inspectorate-5V3573KXHFAJXH6LVC6NSXW37M/
Industry Rethinking Visual Elements And Quality-Of-Life Claims After US FDA Drug Ad Crackdown: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/industry-rethinking-visual-elements-and-quality-of-life-claims-after-us-fda-drug-ad-crackdown-WMXPANFVC5B55GZZQ6IWJG4FRE/
US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/us-fda-adpromo-crackdown-letters-came-from-opdp-staff-not-artificial-intelligence-RKTSXQ5ZV5BPJD4DXGAOS5SS5Q/
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