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Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 1
GDF2025 – D1S17 - Pre-Abbreviated New Drug Application (ANDA) Meetings: Process and Best Practices
Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1
Step-by-Step Process of Generic Drug Development for ANDA Submission
Session 1: ANDA Submission Part 1
Good ANDA Submission and Assessment Practices and Software Support (5of27) Generic Drugs Forum 2018
Advancing Generic Drug Development: Translating Science to Approval – Day 1 – Session 2
Advancing Generic Drug Development Translating Science to Approval Day 1–Session 4 & Closing Remarks
Common Deficiencies with ANDAs for Topical Products: (23of39) Complex Generics 2018
Complex Generics: Topical Products, Part 2
Complex Product Development (3of28) Generic Drugs Forum – Apr. 3-4, 2019
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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 introduction to 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 ... Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of Commissioner of Food and Drugs, Robert M. Califf MD, MACC, delivers his Keynote Address to the 2023 Advancing This presentation provided an overview of the pre- This workshop focused on common issues seen in abbreviated new drug applications ( Master the complex world of the Abbreviated New Drug Lisa Bercu and Sarah Kurtz from the Office of Kelley Burridge, CDER Office of Pharmaceutical Quality (OPQ), discusses OPQ considerations and how to resolve FDA discusses additional topics in complex Katherine Tyner, Associate Director (acting) for Science in CDER's Office of Pharmaceutical Quality, and Christine Le, CDER ...
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