GPhA provides input on GDUFA to FDA


WASHINGTON — The Generic Pharmaceutical Association on Thursday provided input on the Generic Drug User Fee Act process before the Food and Drug Administration. 


"GDUFA is a historic achievement for both FDA and the generic pharmaceutical industry," the association stated. "The association and its members fully support GDUFA objectives with 100% industry-generated funds. In fact, last year the industry contributed $300 million to support the three core public health aims of GDUFA: safety, access and transparency. For GDUFA to be successful it must be implemented in a way that is mindful of the realities of the generic drug marketplace, and continues to incentivize the development of generic drugs for patients."


GPhA urged the FDA to dedicate resources to address the growing backlog of abbreviated new drug applications and prior approval supplement submissions. GPhA also noted that a significant portion of the issues identified during the technical reviews can be classified as "easily correctable deficiencies." Industry can respond to these ECDs within a five day timeframe, GPhA stated. 


"GPhA looks forward to the continued dialogue on improving GDUFA, particularly efforts to make generic drug approvals more predictable and consistent," the association added. "This could include more communication with applicants and continued meaningful interaction with the generic industry during agency development of new guidance or before agency enforcement of draft guidance as final."


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