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.
Science & Research Events
- FDA and CRCG Workshop: Scientific and Regulatory Considerations for Assessment of Immunogenicity Risk for Generic Peptide and Oligonucleotide Drug Products
Dates: Oct. 7-8, 2024 - FDA and CRCG Workshop: Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products
Dates: November 6-7, 2024 - SBIA Webinar: M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms –Implementing the Final Guidance
Date/Time: November 21, 2024, 1-4 p.m. - FDA-CRCG Workshop: Navigating the Transition to Low Global Warming Potential Propellants
Dates: December 4-5, 2024 - Center for Research on Complex Generics events
- CDER Small Business & Industry Assistance (SBIA) events
OGD Science & Research News
- The Fiscal Year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report
- CFD-PK Model for Nasal Suspension Sprays: Validation with Human Adult In Vivo Data for Triamcinolone Acetonide (International Journal of Pharmaceutics, September 2024)
- Anatomically-Detailed Segmented Representative Adult and Pediatric Nasal Models for Assessing Regional Drug Delivery and Bioequivalence with Suspension Nasal Sprays (International Journal of Pharmaceutics, September 2024)
- Impact of Different Packaging Configurations on A Topical Cream Product (Pharmaceutical Research, September 2024)
- Evaluation of Model-Integrated Evidence Approaches for Pharmacokinetic Bioequivalence Studies Using Model Averaging Methods (CPT: Pharmacometrics & Systems Pharmacology, August 2024)
- Effect of Antioxidants in Medicinal Products on Intestinal Drug Transporters
- CDER Impact Stories