Boltres attributed some of the growing burden to syringes being regulated as combination products. She said syringes were historically treated more as container closure systems, where meeting pharmacopeial requirements was sufficient, but are now evaluated as both drug packaging and a device constituent part. That shift, she said, brings additional requirements across regions and agencies, including increased complexity in Europe due to the role of Notified Bodies.She cited industry trends since 2016, sayin ...