ANDA Modifications: US FDA Wants More Formal Facility-Initiated Withdrawals
Facilities that cannot coax an ANDA sponsor to amend their application to exclude a center will have to convince a "less comfortable" FDA with a larger record.
You may also be interested in...
FDA decided against trying to predict upcoming approvals as part of FY 2019 GDUFA program fee calculations, but other adjustments likely increased fee significantly.
FDA's predictions have been pretty consistent; actual submissions haven't been.
Agency officials don't care if DMF holder doesn't give access to its entire facility list; FDA says industry is responsible for listing all facilities that could be used as part of ANDA.