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-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
- Narrow Therapeutic Index Drugs: FDA Experience, Views, and Operations (Publication in Clinical Pharmacology and Therapeutics (CPT) November 11, 2024)
- M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms Guidance and Related Revised PSGs (October 2024)
- Quantitative Volumetric Photoacoustic Assessment of Vasoconstriction by Topical Corticosteroid Application in Mice Skin (Publication for Photoacoustics, October 28, 2024)
- Changes in Drug Crystallinity in a Commercial Tacrolimus Amorphous Formulation Result in Variable Pharmacokinetics (Journal of Pharmaceutical Sciences, October 15, 2024)
- Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques (Pharmaceutical Research, October 7, 2024)
- The Fiscal Year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report
- CDER Impact Stories