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Biden’s FDA Pick Califf to Face Senate Queries on Industry Ties

Bloomberg Law

13 Dec 2021

Stacy Cline Amin spoke to Bloomberg Law about Robert Califf facing questions on his longstanding ties to the pharmaceutical industry and the U.S. Food & Drug Administration’s (FDA) role in combating the COVID-19 pandemic at his confirmation hearing to lead the agency.

According to Stacy, senators will want to explore the agency’s progress in boosting the use of real-world data in drug development.

During his past tenure at the FDA, Califf was a “leading advocate for real-world evidence and clinical trial innovation,” Stacy said. Since then, the pandemic has forced U.S. health leaders to collect data outside of clinical trials, including from patient medical records and mobile devices, to make rapid decisions in the fight against COVID-19.

The Senate will want to examine “what actions FDA should prioritize, and whether his views have changed in light of the increased reliance on real-world evidence and clinical trial flexibilities during the COVID-19 pandemic.”

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