GDUFA Research Outcomes
Mixture APIs
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to complex active pharmaceutical ingredients that are comprised of a mixtures (e.g., polymers) in generic products.
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Current Thinking on Synthetic Peptides in Abbreviated New Drug Applications
Jiang, Jeff
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Challenges and Opportunities for Innovation in Complex Generic Drug Product Development
Jiang, Jeff
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Introduction to complex products and FDA considerations
Jiang, Jeff
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Oligonucleotides: Current Thinking and Analytical Challenges Identified in the Nusinersen PSG Development
Zhang, Deyi
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Developing Product-Specific Guidances on Oligonucleotides for Generic Drug Development
Zhang, Deyi
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Considerations in Submitting Abbreviated New Drug Application of Generic Peptide Drug Products
Zhang, Deyi
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Considerations for Abbreviated New Drug Application of Generic Peptide Drug Products
Zhang, Deyi