Posted by Michael Wonder on 28 Aug 2019
Academics and researchers raise concerns with FDA’s plan for ‘integrated reviews’
28 August 2019 - More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the world are calling on the US Food and Drug Administration (FDA) to not replace its original reviews of medical products with an “integrated review” because of the valuable information that would be lost.
The researchers claimed that such a shift would deprive them of information and data on the clinical studies and trials submitted to FDA, information on the post-marketing requirements, and reviewer concerns with an application that might not be included in a summary document like the integrated review, among other important details.
“The FDA should not replace individual reviews with an integrated review. Rather, an additional document that summarises the individual reviews can be published, as FDA has already been doing in publishing ‘Summary Review’ documents,” the researchers wrote.
