Recombinant Drugs Too Complex For 505(b)(2), Should Go To CBER – Amgen
Using the 505(b)(2) application pathway to approve generic recombinant drug products could lead to an "unlawful regulatory imbalance," Amgen said
Using the 505(b)(2) application pathway to approve generic recombinant drug products could lead to an "unlawful regulatory imbalance," Amgen said