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Activities Report of the Generic Drugs Program (FY 2018) | GDUFA II Quarterly Performance

03:50 EST 31 Jan 2020 | FDA

In section VI(C)(2) of the Generic Drug User Fee Amendments Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (GDUFA II Commitment Letter), FDA committed to publishing quarterly metrics as shown in the table below, and as described in the following notes. The agency completes quarterly reporting in addition to the ongoing monthly and annual reporting that are part of Enhanced Accountability and Reporting under GDUFA II.

Original Article: Activities Report of the Generic Drugs Program (FY 2018) | GDUFA II Quarterly Performance

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