Back to: Facilitating Generic Drug Product Development through Product-Specific Guidances
🔔 Note: Stop playback at 30:02 to complete this lesson.
Presenter
Joseph Kotsybar, PharmD
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)