generic drug product development

Comparative Analyses: Injectable Combination Products (21of35) Complex Generics – Sep. 25-26, 2019

Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1

New drug discovery and development | pre clinical studie | Clinical studies | innovator and generics

Advancing Generic Drug Development Translating Science to Approval Day 2–Session 8 & Closing Remarks

Navigating Controlled Correspondences to Support Generic Drug Development

GDUFA II Training - Pre ANDA Program Pre Submission Meetings, Robert Lionberger

Lab Science to Support Generic Complex Drug Product Assessment

Keynote from Sally Choe, Director, Office of Generic Drugs (OGD)

Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies

Best Practices for Topical Generic Product Development and ANDA Submission–Introduction & Session 1

Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4of39) Complex Generics 2018

Generic Drugs Forum 2022 – Day 2, Session 1

Harmonization and Global Efforts for Safe and Effective Generic Drugs

Dissolution Method Development for Generic Drugs (24/28) Generic Drugs Forum 2017

Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 2

Pre-ANDA Program Update (2of35) Complex Generics– Sep. 25-26, 2019

In vitro bioequivalence testing for topical ophthalmic suspension products (17of39) Complex Generics

Complex Product Characterization/Analysis - Session 2B

Keynote with Sally Choe (1of35) Complex Generics – Sep. 25-26, 2019

The Patient Voice in Generic Medicine Development

Overview of the FDA Product-Specific Guidance Program

Advancing Generic Drug Development: Translating Science to Approval – Day 2 – Session 5

GDUFA II Pre-ANDA Program Meetings: Advice for Success (10of27) Generic Drugs Forum 2018

Considerations of Particle Analysis (12of35) Complex Generics – Sep. 25-26, 2019