Goal Date Confusion: The Downside Of Generic Drug Assessment Transparency
Executive Summary
ANDA sponsors worry launch plans cannot be finalized if US FDA will not inform them whether their application requires a facility inspection.
You may also be interested in...
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.
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.
US FDA To Generic Sponsors: Don't Call Us, We'll GDUFA You
FDA says there are only a few situations where the ANDA status call to the project manager is necessary, and industry seems to agree that review system improvements make the once-contentious check-in process less necessary.