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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. With amazing frequency, the questioner follows up with a twinkle in the eye and a statement that is similar to a rock-star groupie suggesting, “Isn’t he dreamy?”

So, let me tell you, most FDA watchers who long to hear from the agency early and often, and who...

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• By Amanda Maxwell

The EU’s Artificial Intelligence Act, which entered into force on 1 August 2024, is already facing turbulence.

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• By Marion Webb, Shubham Singh, and Nancy Pham

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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
• By Brian Bossetta

The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
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Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.

More from Policy & Regulation

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• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.

More Haste Less Pace? Challenging The ‘Early As Possible’ Principle In Medtech Innovation

 
• By Stuart Grant

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• By Natasha Barrow

Guardant Health’s methylation-based blood test – Shield MCD – showed a specificity of 98.6% and sensitivity of 75% across eight cancer types in its clinical validation data presented at ASCO.