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          Science & ResearchGeneric Drugs Science & Research
  
  	
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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**

Evaluation of Model-Based Bioequivalence Approach for Single Sample Pharmacokinetic Studies
	Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview
	FY2023 Generic Drug Regulatory Science Initiatives Public Workshop (May 11-12, 2023)
	FY 2022 GDUFA Science and Research Report
	Save the Dates for 2023 FDA and CRCG Co-Sponsored Events on Complex Generic Product Topics
	Impact Story:  Developing New Ways to Evaluate Bioequivalence for Topical Drugs
	Impact Story: Modeling Tools Could Modernize Generic Drug Development

                                                                                  Content current as of:
      07/31/2023
              
              
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						  Generic DrugsGeneric Drugs

          
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