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How A Rapid, Well-Messaged US FDA Offense Is Driving Spectators To Their Feet And Twitter Accounts

 
• By Nancy Bradish Myers

Consultant Nancy Bradish Myers examines why US FDA seems to be accomplishing so much under Commissioner Gottlieb’s leadership and how this could inform future leadership selections.

Commissioner Gottlieb speaking at RAPS 2017
What is the "secret sauce" to Commissioner Gottlieb's success?
About The Author

Nancy Bradish Myers, JD, president of Catalyst Healthcare Consulting, is a Washington, DC-based attorney with deep expertise in health-care law and regulation, policy development, and government relations. She served as senior policy counsel in the Office of the FDA Commissioner, as well as special assistant/senior strategic advisor to the FDA acting deputy commissioner for operations. She has been closely involved in drug, biotechnology and medtech regulatory issues for more than 25 years.

“How is FDA doing under Commissioner Scott Gottlieb?” is a question that, as a regulatory policy and strategy consultant, I am asked regularly

So, let me tell you, most FDA watchers who long to hear from the agency early and often, and who benchmark it by the rapid-fire announcements and new initiatives, think FDA is moving

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• By Amanda Maxwell

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More from Policy & Regulation

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• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

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