Science & Research
The Office of Research and Standards, within the FDA's Office of Generic Drugs (OGD), supports the Science and Research program established under the Generic Drug User Fee Amendments (GDUFA). In collaboration with industry and the public, FDA creates an annual list of regulatory science initiatives on generic drugs. The research studies conducted under these initiatives advance public health by contributing to the development of safe and effective generic drugs. The results provide new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products.
Latest Science & Research News
- 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 - The Fiscal Year 2023 (FY23) Generic Drug User Fee Amendments (GDUFA) Science and Research Outcomes Report