Generic Drugs Forum 2022: The Current State of Generic Drugs –

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Sally Choe, Ph.D.
Office of Generic Drugs (OGD) | CDER | FDA

Michael Kopcha, Ph.D., R.Ph.
Office of Pharmaceutical Quality (OPQ) | CDER | FDA
The Generic Drugs Forum (GDF) is an annual, two-day virtual event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice, presenting case studies, and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.
This year’s theme is The Current State of Generic Drugs and presentations will focus on hot topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs.
The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who:
Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.
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