US FDA’s Amy Abernethy Leaves Behind Legacy Of Tech Modernization, Real-World Data
Executive Summary
After slightly more than two years as second-in-command, Abernethy tells the Pink Sheet she’s leaving FDA because the initiatives on which she was focused were starting to develop their own momentum. Abernethy, who also serves as the agency’s acting chief information officer, worked to modernize the FDA’s information technology infrastructure and data capabilities while also exploring ways to confidently use real-world data to support regulatory decision-making.
You may also be interested in...
Flagship's $3.37bn Fund To Grow First-In-Category Firms
Flagship, the investor behind COVID-19 success story Moderna, has raised a huge fund that will be used to create and develop its own companies before spinning them off.
A Whole New Year For Pharma: Macro Pressures Mount Heading Into Q1 Reporting
First quarter earnings preview: US drug pricing reform, an uncertain regulatory outlook and new focus on M&A are rising challenges that could put the industry's growth at risk.
Cavazzoni Helms US FDA Drug Center With OTC Monograph Reform Starting, Novel Switches Next
Patrizia Cavazzoni, who likely represents a somewhat different leadership style for CDER, distinguished herself while leading the center temporarily during the COVID-19 pandemic.