Early Advocacy and Compelling Evidence Are Key to Successfully Seeking Appropriately Stringent Approval Standards for Complex Generics

Lexology February 20, 2024
BakerHostetler

In its eighth annual report,1 the FDA’s Office of Generic Drugs (OGD) made clear that “generic drugs remained a significant public health priority for the FDA.” OGD is pursuing several important initiatives to foster the approval of complex generic drugs. “The GDUFA Science and Research Program is particularly important for . . . complex products, which are harder to develop as generics.”2 “The implementation of GDUFA III . . . brings the generic drug program to yet another level . . . enabl[ing] further regulatory science research around complex and other generic drug development.”3 The FDA is directly enabling generic sponsors: “GDUFA research outcomes also allowed FDA to . . . provide prospective ANDA applicants with scientific and technical advice...

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