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

01:28 – Q1/Q2 Assessment and Requirements for Biowaiver of Injectables

19:56 – Current Thinking and Research On In Vitro Only Approaches for Injectable Suspensions of Drug Substances– A Scientific Discussion

40:03 – Challenges and Considerations in Developing In Vitro Release Testing Methods for Parenteral Suspensions

58:27 – MAPP 5019.1 - Allowable Excess Volume/Content in Injectable Drug and Biological Products

1:22:03 – Session 3 Question & Answer Panel

Session Leads:

Bing Cai, PhD
Director
DLBP I | OLDP | OPQ | CDER

Yan Wang, PhD
Team Lead
DTP I | ORS | OGD | CDER

Speakers:

Xinran Li, PhD
Staff Fellow
DB II | OB | OGD | CDER

Bin Qin, PhD
Staff Fellow
DTP I | ORS | OGD | CDER

William Smith, PhD
Research Fellow
DPQR | OTR | OPQ | CDER

Hongna Wang, PhD
Chemist
DIPAP | OPPQ | OPQ | CDER

Panelists:

Xinran Li, Bin Qin, William Smith, and Hongna Wang

Including:
Utpal Munshi, PhD
Director
DBI | OB | OGD | CDER

David Anderson, PhD
Branch Chief
DMAII | OPMA | OPQ | CDER

Janice Brown, MS
Branch Chief
DIPAP | OPPQ | OPQ | CDER

Learn more at: [ Ссылка ]

-----------------------

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

Upcoming Training - [ Ссылка ]
SBIA Listserv - [ Ссылка ]
SBIA 2022 Playlist - [ Ссылка ]
SBIA LinkedIn - [ Ссылка ]
SBIA Training Resources - [ Ссылка ]
Twitter - [ Ссылка ]
Email - CDERSBIA@fda.hhs.gov
Phone - (301) 796-6707 I (866) 405-5367

свернуть