FDA looked at many different attributes of sponsors and applications to try to determine if any characteristics were predictive of communication of “complete response” letter contents. The small dataset did not turn up many statistically significant associations, but the findings are interesting in the portrait they paint of the applications that received CRLs.
Press Releases Are ‘Incomplete Substitutes’ For FDA Letters
FDA analysis finds few matches between ‘complete response’ letters, press releases. But few specific factors about sponsors and NDAs could clearly be shown to be predictive of disclosure.