FDA “Progressive Approval” And “Exceptional Approval” Pathways Possible Under Senate Bill
By
Derrick Gingery / Email the Author / “The Pink Sheet” Nov. 14, 2011, Vol. 73, No. 46
On Capitol Hill / Word Count: 1030 / Article # 00111114024
Executive Summary
Legislation being drafted by Sen. Kay Hagan, D-N.C., would formalize FDA practices of approving drugs in certain circumstances where the evidence needed for a standard approval cannot be generated.
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