GDUFA Research Outcomes
Oligonucleotide APIs
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to complex active pharmaceutical ingredients that are oligonucleotides, including antisense oligonucleotides (ASOs) and small interfering RNAs (siRNAs), and associated impurities in generic products.
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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 for Abbreviated New Drug Application of Generic Peptide Drug Products
Zhang, Deyi