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  • Cavazzoni and Woodcock

Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni

February 1st, 2021|Comments Off on Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni

Pink Sheet: Informa Pharma Intelligence – January 29, 2021 Nancy Bradish Myers shares views with Sarah Karlin-Smith that approval watchers’ eyes should more appropriately be on what CDER’s Cavazzoni is thinking around the aducanumab Alzheimer’s [...]

  • Janet Woodcock

Woodcock Faces Maze Of Rules To Become Commissioner Nominee

January 25th, 2021|Comments Off on Woodcock Faces Maze Of Rules To Become Commissioner Nominee

Pink Sheet: Informa Pharma Intelligence – January 21, 2021 Nancy Bradish Myers is quoted by the Pink Sheet explaining the potential value of nominating a former Center Director to be a Commissioner. It may be [...]

  • Joe Biden

Biden’s FDA Commissioner Playbook: Build On COVID Innovations To Modernize Agency

January 7th, 2021|Comments Off on Biden’s FDA Commissioner Playbook: Build On COVID Innovations To Modernize Agency

Pink Sheet: Informa Pharma Intelligence – January 6, 2021 Nancy Bradish Myers, President & CEO at Catalyst Healthcare Consulting, explores how the Biden Administration FDA Commissioner pick will determine how significant agency reforms will be [...]

Latest Blog Posts


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 [...]