Back to: Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval
🔔 Note: Stop playback at 17:58 to complete this lesson.
Presenter
Karen Bengtson
Supervisory Regulatory Health Project Manager
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)