Unhappy With GDUFA II? Note It For GDUFA III, FDA Says
Executive Summary
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.
You may also be interested in...
New ANDA Review Pathways: Should You Be A Priority Or Expedited?
Amid confusion about multiple priority and expedited pathways for US generic drug applications, industry asks which are a true advantage.
Complex ANDAs: Early Meetings With FDA Can Generate Bonus Communication
By conducting a product development or pre-submission meeting, sponsors can receive a mid-review cycle meeting for a complex product ANDA.
GDUFA II: More Than 2,000 ANDAs Remain Unclaimed, Large Firms Still Dominate
Firms could find themselves charged multiple US generic drug user fees if affiliates are not identified and ANDAs claimed.