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The Patient Experience Data (PED) in the review documentation has been raised questions on its consistency by the researches at drugmaker Sanofi. The researchers have demanded the FDA to check in with the consistency after the requirements of the 21st Century Act compelled the agency to take up the reviewing process after the approval of the application in the first full year.
It becomes mandatory for the FDA to provide a brief statement on any experience data that was the part of the application. This is applicable to the applications that are submitted after 16th June 2017.