BioSpace

FDA’s new rare disease framework aims to leverage patient voices for better innovation

Inclusion of the patient perspective is currently an “optional” part of the rare disease drug development process, CBER Director Karim Mikhail told BioSpace. Mikhail, along with his CDER counterpart Michael Davis and other agency rare disease leaders, is trying to change that.

By BioSpace

1 min read
FDA’s new rare disease framework aims to leverage patient voices for better innovation
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