Drug Fix: WuXi vs. the Pentagon, New Advertising Citations, And FDA Explores The Limits Of AI

Pink Sheet Editor-in-Chief Nielsen Hobbs, Senior Editor Sue Sutter, and Senior Reporter Maaisha Osman discuss the Pentagon's decision to list WuXi Apptec as a “Chinese military company” (0:58), FDA’s latest adverting enforcement letters (13:02), and the agency’s thoughts on the risks and benefits of relying on AI for regulatory activities (21:16).

More on these topics from the Pink Sheet:

Pentagon Chinese Company Designations Resurface Pharma Supply Chain Concerns

⁠insights.citeline.com/pink-sheet/compliance/di… (insights.citeline.com/pink-sheet/compliance/di…)

US Legislation Targets US-China Dealmaking Amid Fears Of Ceding Biotech Leadership

⁠insights.citeline.com/pink-sheet/legislation/u… (insights.citeline.com/pink-sheet/legislation/u…)

BIOSECURE Legal Lifeline Available For Pharma Companies Using WuXi AppTec … For Now

⁠insights.citeline.com/pink-sheet/compliance/di… (insights.citeline.com/pink-sheet/compliance/di…)

Pentagon Cleared WuXi AppTec Once. Now It Is Being Sued for Changing Its Mind.

⁠insights.citeline.com/pink-sheet/compliance/ma… (insights.citeline.com/pink-sheet/compliance/ma…)

Recent US FDA Ad/Promo Untitled Letters Citing More Email, Internet Issues, Less DTC TV Spots

⁠insights.citeline.com/pink-sheet/compliance/ma… (insights.citeline.com/pink-sheet/compliance/ma…)

Unapproved Uses Safe Harbor Codified In Revised US FDA Payor Communications Guidance

⁠insights.citeline.com/pink-sheet/market-access… (insights.citeline.com/pink-sheet/market-access…)

US FDA Says AI Played Supporting, Summarizing Role In Fast BLA Review

⁠insights.citeline.com/pink-sheet/product-revie… (insights.citeline.com/pink-sheet/product-revie…)

Acting CDER Director Warns AI Over-Reliance Will Trigger GMP Violations

⁠insights.citeline.com/pink-sheet/advanced-tech… (insights.citeline.com/pink-sheet/advanced-tech…)