BIO Wants Expanded Accelerated Approval In PDUFA Instead Of Progressive Approval
By
Derrick Gingery / Email the Author / “The Pink Sheet” DAILY Jan. 23, 2012
Word Count: 1003 / Article # 14120123003
Executive Summary
While it would not grab as much attention as creating a whole new approval pathway, BIO believes tinkering with accelerated approval to give the regulations more clarity and increase its use still could generate the change it wants at FDA.
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