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
03:19 – GDUFA III Labeling Updates and Tips
29:53 – Overview of Major Quality Deficiencies and Approaches Available in GDUFA III
44:17 – Drug Product Quality Tips: Drug-Device Combination Products
01:04:21 – Questions & Panel Discussion
Speakers:
Julie Neshiewat, PharmD, BCPS, CPH
Supervisor
Division of Labeling Review (DLR)
Office of Regulatory Operations (ORO)
Office of Generic Drugs (OGD)
Center for Drug Evaluation & Research (CDER) | FDA
Oluwakemi O. Odesina, PharmD, BCPS, CPH
Labeling Reviewer
DLR | ORO | OGD | CDER | FDA
Kodilichi (Kodi) Echeozo, PharmD, BCPS, CPH
Labeling Reviewer
DLR | ORO | OGD | CDER | FDA
Karen Ireland, MS, PMP, RAC-Drugs
Senior Regulatory Health Project Manager
Division of Regulatory Business Process Manager II (DRBPMII)
Office of Programs and Regulatory Operations (OPRO)
Office of Pharmaceutical Quality (OPQ)
CDER | FDA
Kai Kwok, PhD
Senior Pharmaceutical Quality Assessor
Division of Liquid-Based Drug Products II (DLBP II)
Office of Lifecycle Drug Products (OLDP)
OPQ | CDER | FDA
Panelists:
Julie Neshiewat, Oluwakemi "Kemi" Odesina, Kodilichi (Kodi) Echeozo, Karen Ireland, Kai Kwok
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