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US FDA Urged To Rethink Warning Letters To Avoid ‘Collateral Damage’

 
• By Sue Sutter

Industry attorneys worry US agency is not considering late responses to adverse inspection reports before issuing warnings, and that letters sometimes go beyond the recommendations laid out in existing FDA guidance

Vintage inscription made by old typewriter, warning

FDA should re-evaluate when it issues warning letters, and the language it uses within them, given the collateral damage they can cause for pharmaceutical manufacturers, industry attorneys said at the recent Food and Drug Law Institute (FDLI) annual meeting.

During a panel discussion on Center for Drug Evaluation and Research (CDER) activities and priorities, industry attorneys questioned whether the agency considers late-submitted responses

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