
(AGENPARL) – SILVER SPRING ven 09 giugno 2023 Controlled correspondence is a correspondence submitted to FDA by or on behalf of a generic drug manufacturer or related industry requesting information on a specific element of generic drug product development or concerning certain post-approval submission requirements.
Fonte/Source: http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-controlled-correspondence-enhancements