GDUFA Research Outcomes

Peptide APIs

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to complex active pharmaceutical ingredients that are peptides, including associated impurities in generic products.

• All(30)
• Posters(6)
• Presentations(18)
• Papers(6)

• Demonstrating Complex API Sameness

  Zhang, Deyi

• Assessing Immunogenicity Risk of Peptide Drugs: Generic Drug Perspective

  Pang, Eric

• Regulations, Guidances, and Sameness Assessment for Generic GLP-1 Products

  Pang, Eric

• In Vitro, In Silico Immunogenicity Assessments (IVISIA) of Generic Peptide Drug Products

  Pang, Eric

• PSG Recommendations for Risk-based Comparative Immunogenicity and Impurity Profile Assessment

  Pang, Eric

• Guidance for Peptide Products and Assessing Immunogenicity Risk

  Pang, Eric

• Non-clinical Evaluation of Comparative Immunogenicity Risk of Complex Peptide Products

  Pang, Eric

• Resolving Peptide Drug Challenges Through Pre-ANDA Processes

  Pang, Eric

• Generic Drug User Fee Amendments (GDUFA) Research and the Product-Specific Guidance (PSG) Program for Complex Products: Challenges and Notable Advances

  Kozak, Darby

• Follow up Discussion on FDA Peptide Guidance after Public Comments

  Jiang, Jeff