Academics and researchers raise concerns with FDA’s plan for ‘integrated reviews’
More than 50 academics and researchers from Harvard, Yale, Johns Hopkins and other universities around the world are calling on the 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 the FDA, information on the postmarketing requirements, and reviewer concerns with an application that might not be included in a summary document like the integrated review, among other important details.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
