Quick Overview: Sam Raney from the Division of Therapeutic Performance in CDER's Office of Kelley Burridge, CDER Office of Pharmaceutical Quality (OPQ), discusses OPQ considerations and how to resolve ANDA ... Markham C. Luke from CDER's Office of Generic Drugs discusses

Complex Generics Topical Products Part - Detailed Overview & Context

Sam Raney from the Division of Therapeutic Performance in CDER's Office of Kelley Burridge, CDER Office of Pharmaceutical Quality (OPQ), discusses OPQ considerations and how to resolve ANDA ... Markham C. Luke from CDER's Office of Generic Drugs discusses Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of Priyanka Ghosh from the Division of Therapeutic Performance in the Office of Presenters respond to audience questions. ----------------------------- FDA CDER's Small Business and Industry Assistance (SBIA) ...

Presenters Brock Roughton, Tannaz Ramezanli, Priyanka Ghosh, and Sam Raney answer audience questions. Learn more at ...

Photo Gallery

Complex Generics: Topical Products, Part 1
Complex Generics: Topical Products, Part 2
Generic Topical and Transdermal Products (5of35) Complex Generics– Sep. 25-26, 2019
Overview of Current Science-Based Regulatory Standards (21of39) Complex Generics 2018
Complex Generics: Complex Injectables, Ophthalmic, and Otic Products, Part 2
Common Deficiencies with ANDAs for Topical Products: (23of39) Complex Generics 2018
Product-Specific Guidances for Complex Generic Drugs
Product Development Considerations for Generic Topical Products (22of39) Complex Generics 2018
Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019
Bioequivalence for Generic Topical and Transdermal (6of35) Complex Generics– Sep. 25-26, 2019
Office of Generic Drugs Keynote (1of39) Complex Generics 2018
Panel Discussion- Delivery/Dosage Forms: Topical and Transdermal (25of39) Complex Generics 2018
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