The US FDA will be releasing in the next six months a guidance on the clinical evaluation of targeted therapies for rare disease subsets as part of a broader "medical innovation development plan"designed to facilitate the development of breakthrough new treatments, agency Commissioner Scott Gottlieb announced.
US FDA 'Medical Innovation Development Plan' Outlined By Gottlieb
Testifying before Senate subcommittee, FDA commissioner put his plans for facilitating new drug development front and center, a shift from his many past discussions about generic drug development.
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