
(AGENPARL) – SILVER SPRING lun 27 marzo 2023 The Pre-ANDA Program is designed to assist prospective generic drug applicants in developing more complete submissions, promote a more efficient and effective ANDA assessment process, reduce the number of assessment cycles, and facilitate approval of complex generic drug products.
Fonte/Source: http://www.fda.gov/industry/generic-drug-user-fee-amendments/gdufa-iii-enhancements-pre-anda-program