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Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019
Session 1: ANDA Submission Part 1
GDF2025 – D1S17 - Pre-Abbreviated New Drug Application (ANDA) Meetings: Process and Best Practices
Step-by-Step Process of Generic Drug Development for ANDA Submission
Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1
Product Development Considerations for Generic Topical Products (22of39) Complex Generics 2018
Common Deficiencies with ANDAs for Topical Products: (23of39) Complex Generics 2018
Complex Generics: Topical Products, Part 1
Complex Product Development (3of28) Generic Drugs Forum – Apr. 3-4, 2019
GDUFA II Training - Pre ANDA Product Development Meetings, Robert Lionberger
GDUFA II Training - Pre ANDA Program Pre Submission Meetings, Robert Lionberger
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Last Updated: October 3, 2026
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Priyanka Ghosh, PhD, Acting Team Lead from the Division of Therapeutic Performance (DTP-I) delivers the Tannaz Ramezanli, PhD, Pharmacologist from the Division of Therapeutic Performance (DTP-I) presents the Practical ... Hirten Patel, PhD, Staff Fellow from the Division of Bioequivalence II (DB-II) presents the Practical Considerations Related to IVPT ... Commissioner of Food and Drugs, Robert M. Califf MD, MACC, delivers his Keynote Address to the 2023 Advancing Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of Master the complex world of the Abbreviated New Drug This presentation provided an overview of the pre- This workshop focused on common issues seen in abbreviated new drug applications ( Kelley Burridge, CDER Office of Pharmaceutical Quality (OPQ), discusses OPQ considerations and how to resolve FDA discusses topics in complex Katherine Tyner, Associate Director (acting) for Science in CDER's Office of Pharmaceutical Quality, and Christine Le, CDER ... In this presentation, Robert Lionberger will discuss the GDUFA II pre-
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