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US FDA's Integrated Review Document Would Dramatically Downsize Public Information

 
• By Bridget Silverman

Interdisciplinary review template provides efficient summaries of data, but without the insight into regulatory thinking made possible by disclosure of decisional memoranda, subject area reviews, and meeting minutes.

Bussinessman

The sample integrated review document posted by the US Food and Drug Administration to demonstrate its new proposed integrated review process and documentation template suggests that the agency is planning to make the review process even less transparent than under the action package streamlining that began one year ago.

“FDA believes that the format and content of the new integrated review will provide a clearer description of FDA’s analysis...

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