FDA Proposal Would Let Deemed Biologics Reference Master File Info

In a bid to avoid disruptions and potential shortages as biologic products transition from being regulated as drugs to being licensed as biologics, FDA issued a proposed rule Thursday (June 27) that would let those products continue to include certain information, by reference, in drug master files even after they complete their transition. Under current FDA regulations, biologics are not allowed to include reference information in master files related to the drug substance or intermediates. There currently are 89 biologic...