Back to: Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval
🔔 Note: Stop playback at 1:06:42 to complete this lesson.
Presenters
Yan Wang, PhD
Lead Pharmacologist
Division of Therapeutic Performance I
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Eleftheria Tsakalozou, PhD
Senior Pharmacologist & Acting Team Lead
Division of Quantitative Methods and Modelling
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)