Lack Of Priority? No ANDAs Approved Using Expedited Pathway In FY 2018
US FDA also refused to receive many priority generic drug applications, suggesting the expedited pathway may not be working as intended quite yet.
You may also be interested in...
FDA relates new record to its plan to increase access to affordable drugs, but Association for Accessible Medicines says approvals alone will not increase competition.
US FDA's expedited pathway for generics seems to provide more benefits for amendments than for original ANDAs.
OGD Director Uhl says program is now in balance between the number of submissions and agency review actions.