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Complex Generics: Complex Injectables, Ophthalmic, and Otic Products, Part 2

FDA discusses additional topics in complex generics, complex injectables, ophthalmic, and otic products. Includes responses to audience in a question-and-answer panel. Presenters and presentations include:

Challenges in the Approval of Complex Otic and Ophthalmic Generic Products: Bioequivalence Perspectives
Chunsheng Zhao, PhD; DB III|OB|OGD|CDER

Challenges in the Approval of Complex Otic & Ophthalmic Generic Products: Quality Perspectives
Poonam Chopra, PhD; DLBP II|OLDP|OPQ|CDER

Physiological Based Pharmacokinetic Modeling and Simulation to Support Generic Ophthalmic Drug Product Development and Regulatory Decision Making
Mingliang Tan, PhD; DQMM|ORS|OGD|CDER

Q&A Panel (Including all above presenters):
Asif Rasheed, PhD; DLBPI|OLDP|OPQ|CDER
Kai Kwok, PhD; DLBPII|OLDP|OPQ|CDER
Yan Wang, PhD; DTP I|ORS|OGD|CDER

For slides and additional information: https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-translating-science-approval-09212021-09222021
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Complex Generics: Complex Injectables, Ophthalmic, and Otic Products, Part 1

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