GDUFA Research Outcomes
Other Generics Research
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to other research relevant to generic products.
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Risk Assessment and Management for Formulation Change Using Model Integrated Approach
Zhao, Liang
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Impact of Modeling and Simulation on Drug Product Life Cycle Management
Zhao, Liang
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Computational Pharmaceutics: Scientific Gaps and Forthcoming Research to Modernize Regulatory Science
Zhao, Liang
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Pre-ANDA Program
Arora, Sumit
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The GDUFA II Pre-ANDA Program for Complex Products
Andre, Kris
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GDUFA II: Pre-ANDA Meetings for Complex Generic Products
Andre, Kris
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Practical Tips on Using the CDER NextGen Collaboration Portal
Andre, Kris
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Pre-ANDA Meeting or Controlled Correspondence?
Andre, Kris
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Complex Products – GDUFA II Pre-ANDA Program
Andre, Kris
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Using the ePortal for Pre-ANDA Meeting Requests
Andre, Kris