GDUFA Research Outcomes
Other Generics Research
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.
-
Overview of Pre-ANDA Meeting Program
Hakeem, Susan
-
Characterization and Comparative Evaluation Strategies to Demonstrate Complex Excipient Sameness
Qin, Bin
-
GDUFA II: Pre-ANDA Program Metrics and Tips for Success
Prodduturi, Suneela
-
How can Scientific Advancements Help Align Global Development of Complex Generic Products
Jiang, Wenlie
-
Scientific Gaps that Impact the Prediction of Fed BE Studies
Ni, Zhanglin
-
Development of Complex Generic Drugs in the United States
Luke, Markham C
-
Careers in Pharmacology Symposium: The FDA
Luke, Markham C
-
Non-Complex Drug Products and Product-Specific Guidances
Kim, Myong Jin
-
Complex Product Workshop
Luke, Markham
-
Evaluating Therapeutic Performance of Complex Generic Drugs for Pulmonary Delivery: The FDA Generic Drug Approval Process
Luke, Markham