US FDA’s Inner Circle Takes Shape: Shah Seen As Potential Successor To Abernethy
Anand Shah returns to FDA as deputy commissioner; like Abernethy, he is an oncologist with a background in big data.
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Shah, deputy commissioner for medical and scientific affairs, has been overseeing FDA’s COVID-19 Pandemic Recovery and Preparedness Plan. His departure the week of 20 January follows that of FDA Chief Counsel Amy Amin, whose resignation led to dueling appointments to temporarily fill her post.
Principal deputy commissioner Amy Abernethy cites IND safety reporting and oncology review pilot program as areas that would benefit from enabling receipt of sponsor data in real time; plan describes near-term strategy for modernizing agency’s technical infrastructure, developing technology tools around regulatory ‘use cases’ and improving collaborations with data and tech companies.
Senate confirmation includes fewest supporting votes for any candidate ever as agency tackles budget, user fees and other issues.