ARTICLE | Regulation
FDA’s CRL transparency not as radical as it seems
Despite claims of ‘radical transparency,’ the new database includes only CRLs for products that are now approved — all of which were already public
July 10, 2025 9:27 PM UTC
FDA Commissioner Marty Makary’s announcement that he was releasing complete response letters set hearts racing and fingers racing to keyboards around the world. Passions dimmed, however, upon closer examination of the promised “radical transparency.”
The big reveal is limited to CRLs for approved products. ...
BCIQ Company Profiles