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US FDA's Integrated Review Doc: Industry Says Don't Lose The Detail

 
• By Derrick Gingery

Stakeholders, some worried about "groupthink," tell the US FDA they want the individual discipline comments on newly approved drugs to stay in action packages because of the valuable insights they provide.

bundles bales of paper documents. stacks packs pile on the desk in the office
Sponsors like the detailed memos explaining the FDA's thoughts on new drug approvals and don't want them sacrificed for the integrated review document. • Source: Shutterstock

Groups across the pharma spectrum argued, for different reasons, that the US Food and Drug Administration should retain the detailed memos and individual assessor opinions currently available in its drug approval packages when implementing the integrated review document.

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