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.

• All(16)
• Posters(2)
• Presentations(14)
• Papers(0)

• Introduction to complex products and FDA considerations

  Jiang, Jeff

• Oligonucleotides: Current Thinking and Analytical Challenges Identified in the Nusinersen PSG Development

  Zhang, Deyi

• Developing Product-Specific Guidances on Oligonucleotides for Generic Drug Development

  Zhang, Deyi

• Considerations for Abbreviated New Drug Application of Generic Peptide Drug Products

  Zhang, Deyi

• Evaluation of Quantitative Capsule Rupture Test Methods and Data Variability in Generic Omega-3 Capsule Applications

  Liu, Hao; Suh, Min Sung; Kozak, Darby; Pang, Eric

• Scientific Considerations for Synthetic Peptides Referencing Peptide Drugs of rDNA Origin

  Hu, Ping; Zhang, Deyi; Kozak, Darby; Jiang, Xiaohui