Orphan Products Mostly Approved With Regulatory Flexibility, NORD "Catalog" Finds
By
M. Nielsen Hobbs / Email the Author / “The Pink Sheet” Oct. 17, 2011, Vol. 73, No. 42
Regulatory Update / Word Count: 1281 / Article # 00111017021
Executive Summary
The National Organization for Rare Disorders’ campaign to get FDA to codify a flexible approach on approving orphan drugs is now bolstered by an analysis that concludes most of the agency’s approval decisions for such products already use unconventional efficacy standards.
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