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
- SBIA Public Workshop: Advancing Generic Drug Development: Translating Science to Approval | September 24-25, 2024
- Evaluation of In Vitro Skin Permeation of Clascoterone from Clascoterone Topical Cream, 1% (w/w), AAPS PharmSciTech | August 2024
- Development and Comparison of Model-Integrated Evidence Approaches for Bioequivalence Studies with Pharmacokinetic Endpoints, CPT: Pharmacometrics & Systems Pharmacology | August 2024
- Topical Semisolid Drug Product Critical Quality Attributes with Relevance to Cutaneous Bioavailability and Pharmacokinetics: Part I-Bioequivalence of Acyclovir Topical Creams, Pharmaceutical Research | July 2024