Last Thursday, in a surprise move, the FDA made 89 previously unpublished complete response letters (CRLs), which it had issued to sponsors since 2024, available via its openFDA database. Going forward, the agency says that all CRLs will be published “promptly after they are issued to sponsors.” Our Medical Advisor, Michael Haichin, was quick to spot the news, and trawled through the database in…
