CONTEXT:  Changes at the FDA as the principal deputy commissioner moves on.

IMPACT:  Low

READ TIME:  1 min

Quality Level Mean [1 – 10]:  7

1. ““Throughout multiple commissioner transitions and a historic pandemic, Amy’s focus on the FDA’s core technology operations has resulted in a remarkable modernization of the agency’s technology and data practices.”” 

2. “Abernethy’s agency bio describes her as a hematologist/oncologist and palliative medicine physician, a clinical data expert and clinical researcher with expertise in cancer data, real-world evidence, clinical trials, health services research, patient-reported outcomes, clinical informatics and patient-centered care.” 

3. “She joined the agency in 2019 after serving as chief medical officer, chief scientific officer, and senior VP for oncology at Roche’s electronic health records firm Flatiron Health, where she led the research oncology, clinical operations and data science teams.” 

4. “Abernethy’s legacy at the FDA will be long-lasting, according to Woodcock, who credited Abernethy’s leadership in modernizing the agency’s use of data and analysis as a saving grace during COVID-19.” 

5. “Abernethy “rapidly assembled flexible teams and projects to understand how novel data and rigorous analysis techniques could be deployed in support of the FDA’s response to the pandemic,” Woodcock wrote.” 

Source URL: https://www.medicaldesignandoutsourcing.com/fda-second-in-command-to-leave-agency/