GDUFA Regulatory Science
In July 2012, Congress passed the Generic Drug User Fee Amendments (Title III of the Food and Drug Administration Safety and Innovation Act (Public Law 112-144). FDA agreed in the GDUFA Commitment Letter to immediately begin work on the FY 2013 Regulatory Science Plan and to consult with industry and the public to create an annual list of regulatory science initiatives specific to research on generic drugs. The research studies conducted under these initiatives will advance the public health by providing access to safe and effective generic drugs. The regulatory science results will provide new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products in all product categories. The Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating within FDA as well as externally through grants or contracts.
- Public Workshop October 2 - 3, 2017: Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review
- Public Workshop on October 6, 2017: Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing
- Public Workshop October 20, 2017: Overcoming Barriers to the Development of, and Improving Patient Access to, Topical Dermatological Generic Drug Products
In the News
- Lamotrigine Generics Equal to Brand�Single-dose study of generic antiepileptic drug finds minimal differences (June 27, 2017)
- US FDA Pushing For Generic Alternatives To Long-Acting Injectables, Implants (March 21, 2017)
- What Makes an Ophthalmic Generic Bioequivalent? A researcher discusses how the FDA establishes the bioequivalence of generic ophthalmic drugs (November 1, 2016)
- AES: Three studies show generic lamotrigine equals Lamictal (December 18, 2015)
- Influence of Formulation Factors on the Aerosol Performance of Suspension and Solution Metered Dose Inhalers: A Systematic Approach.
- Characterization of temperature profiles in skin and transdermal delivery system when exposed to temperature gradients in vivo and in vitro.
- Mechanistic oral absorption modeling and simulation for formulation development and bioequivalence evaluation: report of an FDA public workshop.
- Scientific and regulatory considerations for generic complex drug products containing nanomaterials.
- Model-Based Approach for Optimizing Study Design and Clinical Drug Performances of Extended-Release Formulations of Methylphenidate for the Treatment of ADHD.
Opportunities for Collaboration
- Broad Agency Agreement (see FDABAA-17-00123, Section 3.) â applications are accepted on a continuous basis
Public Meetings and Workshops
- FY 2017 Generic Drug Research Public Workshop
- FY 2016 Regulatory Science Initiatives Part 15 Public Meeting
- FY 2015 Regulatory Science Initiatives Part 15 Public Meeting
Notable Guidances Related to Regulatory Science:
- Draft Guidance: Fluticasone Propionate; Salmeterol Xinafoate
- Draft Guidance: Albuterol sulfate
- Draft Guidance: Cyclosporine
- Draft Guidance: Conjugated Estrogens
- Office of Generic Drugs FY 2017 Regulatory Science Research Report
- GDUFA Commitment Letter: Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017
- FY 2015 GDUFA Regulatory Research Priorities
- FY 2015 Awarded GDUFA Regulatory Research Contracts and Grants
- Office of Generic Drugs FY 2016 Regulatory Science Research Report
- Draft GDUFA II Commitment Letter
- FY 2017 GDUFA Regulatory Science Priorities
- FY 2016 Awarded GDUFA Regulatory Research Contracts and Grants