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Complex Generics: Complex Injectables, Ophthalmic, and Otic Products, Part 1

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

Advances in Iron Colloid Products: Product-Specific Guidance (PSG) Discussion
Wenlei Jiang, PhD; IO|ORS|OGD|CDER

Advances in Iron Colloid Products: Quality Considerations When Conducting Comparability Studies
Yiwei Li, PhD; DPMA IV|OPMA|OPQ|CDER

Injectable Suspensions: Tools and Methods Bridging the In Vivo and In Vitro Gap
Bin Qin, PhD; DTP I|ORS|OGD|CDER

Q&A Panel (Including all above presenters):
Bruce Lerman, PhD; DB I|OB|OGD|CDER
Darby Kozak, 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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