FDA Generic Drugs Program posts first GDUFA II monthly performance activities report

The FDA Generic Drugs Program has posted the first new monthly performance metrics as outlined in the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II), implemented on October 1, 2017. Enhanced accountability and reporting are an important part of the GDUFA II “commitment letter” – the negotiated agreement between the FDA and regulated industry. The FDA is committed to meeting GDUFA II performance goals and to continuing its mission to review and approve generic drug applications that provide access to safe, effective, affordable, high quality medicines for all Americans.

Resources

• Enhanced Accountability and Reporting in GDUFA II
• Activities Report of the Generic Drug Program
• Section VI.C of the GDUFA II Commitment Letter provides additional information about performance reporting in GDUFA II