1. Pink Sheet

Rare Disease Challenges At US FDA: CDER Director Says More Staff, Not Reorganization, Will Fix Issues

 
• By Derrick Gingery

Rather than changing the agency's structure to create more focus on rare diseases, Patrizia Cavazzoni wants funding for people to do the necessary work.

company reorganization
Advocates continue pushing for a Rare Disease Center of Excellence at the FDA, despite agency opposition. • Source: Alamy

Hiring, not reorganization, is the answer to rare disease expertise issues at the US Food and Drug Administration’s Center for Drug Evaluation and Research, Director Patrizia Cavazzoni said.

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