Catalyst Insight 2018-08-21T21:53:57+00:00

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How a Rapid and Well Messaged FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts

August 21st, 2018|Comments Off on How a Rapid and Well Messaged FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts

The Pink Sheet- “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 [...]

  • Executive Insights. Insider's view. Nancy Bradish Myers

The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

April 20th, 2018|Comments Off on The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

Med Device Online – In this “Insider’s View” column, Catalyst President Nancy Bradish Myers examines the coming wave of digital health, what FDA is signaling through its recent moves in the digital health space, and [...]

  • Shutdown

Shutdown Winds Down: Short ‘Lapse Period’ Likely Means Few Disruptions At US FDA

January 22nd, 2018|Comments Off on Shutdown Winds Down: Short ‘Lapse Period’ Likely Means Few Disruptions At US FDA

The Pink Sheet- This article looks at the impact of the recent government shutdown on FDA and includes Catalyst’s perspectives the challenges involved; Catalyst President Nancy Myers notes that timelines for a number of FDA [...]

  • Shutdown

How a government shutdown could affect drug safety, flu response, and more

January 17th, 2018|Comments Off on How a government shutdown could affect drug safety, flu response, and more

In this article, Catalyst’s Jill Hartzler Warner provides context for a potential future government shutdown, based on her experience at FDA. The article explores the potential impact of a federal government shutdown across a range [...]

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RWE at the Tipping Point: From Registries to Artificial Intelligence, RWE is Poised to Accelerate Medical Product Development

May 24th, 2018|Comments Off on RWE at the Tipping Point: From Registries to Artificial Intelligence, RWE is Poised to Accelerate Medical Product Development

By Anne McNickle This is an exciting time for those of us interested in RWE development. Digital technologies and advanced computing capabilities are enabling the generation of RWE continuously, and from sources that have traditionally [...]

Artificial Intelligence (AI): Coming to a Policymaker Near You

April 2nd, 2018|Comments Off on Artificial Intelligence (AI): Coming to a Policymaker Near You

By Nancy Bradish Myers It’s as if Artificial Intelligence just reached the DC area and policy makers need to think about it. Software companies, academic institutions and innovative companies hoping to develop and harness the [...]

Digital Medicine is Here: Why the Combination of Abilify and Proteus’ Ingestible Sensor is “Sweet”!

November 14th, 2017|Comments Off on Digital Medicine is Here: Why the Combination of Abilify and Proteus’ Ingestible Sensor is “Sweet”!

By Nancy Bradish Myers Yahooooo! What a thrill it is to finally have the first digital medicine approved by the FDA: Abilify Mycite (aripiprazole + Ingestible Event Marker). When I visualize it, it’s like the [...]