Unhappy With GDUFA II? Note It For GDUFA III, FDA Says
US agency says it is implementing generic drug user fee program as outlined in commitment letter and any changes should be discussed at negotiations for the 2022 renewal.
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Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.
By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.
Firms could find themselves charged multiple US generic drug user fees if affiliates are not identified and ANDAs claimed.