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. This year the GDF presentations will focus on hot topics such as GDUFA III updates, information and technology, and complex generics.

Timestamps

03:00 – An Overview of Pre-ANDA meetings under GDUFA III

22:52 – Abbreviated New Drug Application (ANDA) Meeting Requests

43:03 – GDUFA III Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings

58:38 – A New GDUFA III Meeting: Post-CRL (Complete Response Letter) Scientific Meeting

01:16:09 – Questions & Panel Discussion

Speakers:

Savita Nigam, PhD
Senior Project Manager
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation & Research (CDER) | FDA

Tina T. Nhu, PharmD, Mc. PM, BSPharm
Commander, United States Public Health Service (USPHS)
Team Leader, Regulatory Project Manager
Division of Project Management (DPM)
Office of Regulatory Operations (ORO)
OGD | CDER | FDA

April Braddy, PhD, RAC
Director
Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB)
OGD | CDER | FDA

Tao Bai, PhD
Senior Advisor
OB | OGD | CDER | FDA

Panelists:

Savita Nigam, Tina Nhu, April Braddy, Tao Bai, and

Karen Bengtson
Supervisory Regulatory Health Project Manager
Office of Regulatory Science (ORS)
OGD | CDER | FDA

Parth Soni, PharmD, MBA, PMP
Regulatory Project Manager
Division of Project Management (DPM)
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evaluation & Research (CDER) | FDA

Xuan-Mai “Mai” Nguyen, PharmD
Regulatory Project Manager
Division of Project Management (DPM)
ORO | OGD | CDER | FDA

Learn more at: [ Ссылка ]

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