The U.S. Food and Drug Administration (FDA) has been called by multiple organizations to clarify its “regulatory flexibility” with orphan drug reviews, according to Michael Mehzer, RAPS. FDA released a draft guidance in August addressing the most common issues faced by drugmakers developing treatments for rare diseases. While many organizations, such as the National Organization for Rare Disorders (NORD), support the guidance, they request more specific information and examples on nonclinical studies, national history studies, endpoint identification, and trial design.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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