Sandoz Sues FDA For Inaction On Omnitrope NDA
Lawsuit seeks a court declaration that the 505(b)(2) pathway “can be used for protein-based biologic drugs regulated under Section 505 of the FD&C Act.”
Lawsuit seeks a court declaration that the 505(b)(2) pathway “can be used for protein-based biologic drugs regulated under Section 505 of the FD&C Act.”