If FDA determines that the proposed manufacturing change to an approved product
was submitted incorrectly as a CBE, FDA will notify the applicant that the
proposed change is a major change that requires approval before the product made
with the change can be distributed. The applicant must resubmit the change as a
PAS along with payment of a PAS fee.
The criteria for submitting information as a CBE or a PAS were not changed by
GDUFA. For additional information, please refer to 21 CFR 314.70, as well as
related guidances, including, but not limited to, Scale-Up and Post Approval
Changes (SUPAC) and Changes to an Approved New Drug Application (NDA) or
ANDA.