GDUFA

Facility Readiness Goal Date Decisions Under GDUFA

Facility Readiness Goal Date Decisions Under GDUFA

FDA

The Generic Drug User Fee Amendments (GDUFA) aim to streamline the approval process for generic drugs, ensuring timely access to affordable medications. A crucial aspect of this process is the Facility Readiness Goal Date Decisions, which influence the FDA’s timelines for reviewing and approving generic drug applications. Key Highlights from ... Read More