Targeted Therapies On FDA’s Orphan Designation Radar
As personalized medicine continues to grow, FDA is watching to see if there is a rise in orphan designations for products targeting a “smaller slice” of a common disease.
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US FDA contemplating how to match orphan designation process with drug development moving to molecularly-targeted therapies.
Preliminary study results suggest policy tweaks may not be necessary, even as an oncology orphan product rush appears to be coming.
FDA can improve drug pricing by limiting the number of orphan designations, AHIP argues; worryingly for industry, the agency appears to be already thinking along similar lines.