FDA Orphan Approval Flexibility Remains Steady As Pressure Increases
Frank Sasinowski updates his 2012 landmark analysis and finds that FDA maintained its rate of flexibility in the evidentiary standards for approval of orphan products.
You may also be interested in...
A better description of the US FDA’s regulatory flexibility may be necessary, but tinkering with the foundational law for rare disease drug development could open the door for more substantial and unwanted changes.
Attorney Frank Sasinowski says the agency should include new "boilerplate language" in official documents describing scientific flexibility for orphan drug approval requirements.
Reviewer expertise may be better leveraged in more focused roles, but basic tenets of rare disease program should not fundamentally change as part of proposed Office of New Drugs reorganization.