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Is The US FDA At A Tipping Point?

Executive Summary

Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.

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Woodcock: COVID Is Not The Time For Structural Changes At US FDA

Acting FDA Commissioner Janet Woodcock says FDA is interested in establishing new ‘Centers of Excellence’ but the current environment is not the right time to make changes at the agency. Woodcock also talked about where FDA will spend its new pandemic money and its reexamination of accelerated approval drugs in a wide-sweeping conversation with the Alliance for a Stronger FDA.

Woodcock Era At CDER Ends: Cavazzoni Becomes Permanent Director Of US FDA’s Drug Center

Patrizia Cavazzoni, who likely represents a somewhat different leadership style for CDER, distinguished herself while leading the center temporarily during the COVID-19 pandemic.

Roxadustat Approval Might Hinge On Additional Safety Analyses After FibroGen Admits Manipulating Data

With superiority over epoetin apparently off the table, FibroGen and AstraZeneca expect a US FDA advisory committee in July, and hope that additional safety analyses for roxadustat will help support a positive overall risk-benefit profile.

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