Generic Drug Research Publications & Resources
The results of our science and research often provide the generic drug industry with new methodologies and tools to help establish drug equivalence standards and support the development of, and access to, safe, effective, and high-quality generic drug products for the American public. We regularly share these results through webinars, publications (journal articles, presentations and posters), and impact stories.
Webinars
- An Overview of Challenges and Opportunities in the Development of Complex Generic Drug Products
Presenter: Dr. Xiaohui "Jeff" Jiang, Deputy Director, Division of Therapeutic Performance in the Office of Generic Drugs - Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products
Presenter: Kim Witzmann, MD, Medical Officer, Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs (PDF of presentation slides) - FDA Champions Research to Make Complex Generic Transdermal Products Available to Patients
Presenter: Sam Raney, PhD, Lead for Topical and Transdermal Drug Products, Office of Research and Standards, Office of Generic Drugs - Pioneering Modeling Methodologies in Generic Drug Development
Presenter: Liang Zhao, PhD, Director, Division of Quantitative Methods and Modeling in the Office of Research and Standards, Office of Generic Drugs, FDA
OGD Science & Research News
- Effects of Formulation Variables on Lung Dosimetry of Albuterol Sulfate Suspension and Beclomethasone Dipropionate Solution Metered Dose Inhalers (AAPS PharmSciTech, June 2018)
- Nanotechnology Characterization Laboratory Unveils New Technical Services for Drug Developers (National Cancer Institute, March 2018)
- Modeling to Speed Tricky Generic Development (AAPS News, February 2018)
- Paying it Forward: A kidney transplant patient shares how joining a clinical trial helped her family — and others (University of Cincinnati Health, December 2017)
- Lamotrigine Generics Equal to Brand—Single-dose study of generic antiepileptic drug finds minimal differences (MedPage Today, June 2017)
- US FDA Pushing For Generic Alternatives To Long-Acting Injectables, Implants (The Pink Sheet, March 2017)
- What Makes an Ophthalmic Generic Bioequivalent? A researcher discusses how the FDA establishes the bioequivalence of generic ophthalmic drugs (Ophthalmology Management, November 2016)
- AES: Three studies show generic lamotrigine equals Lamictal (Clinical Neurology News, December 2015)
Impact Stories
- Modeling Tools Could Modernize Generic Drug Development
- Developing New Ways to Evaluate Bioequivalence for Topical Drugs
- Developing the Tools to Evaluate Complex Drug Products: Peptides
- Overcoming Challenges to Evaluating Bioequivalence in Complex Drugs
- Addressing Concerns About the Quality of Generic Drugs for Treating Epilepsy
GDUFA Articles, Publications & Posters
|
Journal Articles |
Presentations |
Posters |
|---|---|---|
| FY 2022 | FY 2022 | FY 2022 |
| FY2021 | FY2021 | FY2021 |
| FY 2020 | FY 2020 | FY 2020 |
| FY 2019 | FY 2019 | FY 2019 |