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BIO Wants Expanded Accelerated Approval In PDUFA Instead Of Progressive Approval

 
• By Derrick Gingery

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.

The Biotechnology Industry Organization has backed off its calls for a new progressive approval pathway for drugs, instead favoring an expansion and clarification of the existing accelerated approval.

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