1. Medtech Insight

‘The Power Of Persuasion’: FDA Ombudsman Discusses Her Role

 
• By Elizabeth Orr

During a recent webinar, 20-year FDA chief ombudsman Laurie Lenkel explained why her office sees so many device-related cases and what and ombudsman can, and cannot, do for industry. 

Definition of the word ombudsman in a dictionary.
• Source: Shutterstock

Ombudsmen within the US Food and Drug Administration can play a powerful role in resolving disputes between industry and agency staff. But the position holds no official power beyond “the power of persuasion,” according to Laurie Lenkel, who has been the FDA’s chief ombudsman since 2003.

Lenkel spoke during a 30 August webinar sponsored by the Alliance for a Stronger FDA.

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