This workshop focused on common issues seen in abbreviated new drug applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development, and pre-ANDA meeting discussions, and examined various areas of innovative science and cutting-edge methodologies behind generic drug development. This workshop also provided some insight into upcoming GDUFA III enhancements.

Timestamps

02:40 – Nasal Products: Current Landscape and Recent Advancements

18:50 – Alternative BE Approaches and Considerations for Nasal Products

38:30 – Mechanistic Modeling and Realistic In Vitro Models to Facilitate Development of Generic Nasal Drug Products

56:31 – In Vitro Characterization of Nasal Powder Drug Products

1:11:43 – Session 6 Question & Answer Panel

Session Leads:

Bryan Newman, PhD
Team Lead
DTP I | ORS | OGD | CDER

Changning Guo, PhD
Supervisory Chemist
DCDA | OTR | OPQ | CDER

Speakers:

Susan Boc, PhD
Scientific Researcher
DTP I | ORS OGD | CDER

Ross Walenga, PhD
Senior Chemical Engineer
DQMM | ORS | OGD | CDER

Nick Holtgrewe, PhD
Chemist
DCDA | OTR | OPQ | CDER

Panelists:

Bryan Newman, Ross Walenga, and Nick Holtgrewe

Including:
Ke Ren, PhD
Supervisory Pharmacologist
DB III | OB | OGD | CDER


Learn more at: [ Ссылка ]

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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