GDUFA Research Outcomes

Data Analytics and AI

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to data analytics and artificial intelligence (AI) for generic product development and assessment, including the development of natural language processing (NLP) and machine learning (ML) tools

• All(101)
• Posters(25)
• Presentations(27)
• Papers(49)

• Modified Regulatory Pathways to Approve Generic Drugs in the Us and a Systematic Review of Their Outcomes

  Kesselheim, Aaron; Polinski, Jennifer; Fulchino, Lisa; Isaman, Danielle; Gagne, Joshua

• Forces Influencing Generic Drug Development in the United States: a Narrative Review

  Lee, Chia-Ying; Chen, Xiaohan; Romanelli, Robert; Segal, Jodi

• Transporters in Regulatory Science: Notable Contributions from Dr. Giacomini in the Past Two Decades

  Zhang, Lei; Liu, Qi; Huang, Shiew Mei; Lionberger, Robert

• Factors That Have an Impact on Abbreviated New Drug Application (ANDA) Submissions

  Wittayanukorn, Saranrat; Rosenberg, Matthew; Schick, Andreas; Hu, Meng; Wang, Zhong; Babiskin, Andrew; Lionberger, Robert; Zhao, Liang

• Comparative Outcomes of Treatment Initiation With Brand vs. Generic Warfarin in Older Patients

  Desai, Rishi; Gopalakrishnan, Chandrasekar; Dejene, Sara; Sarpatwari, Ameet; Levin, Raisa; Dutcher, Sarah; Wang, Zhong; Wittayanukorn, Sara; Franklin, Jessica; Gagne, Joshua

• Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness

  Gagne, Joshua

• Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

  Fang, Lanyan; Kim, Myongjin; Li, Zhichuan; Wang, Yaning; Diliberti, Charles; Au, Jessie; Hooker, Andrew; Ducharme, Murray; Lionberger, Robert; Zhao, Liang

• Comment on: “Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs”

  Suggs, Courtney; Levin, Robert; Mosholder, Andrew; Swain, Richard; Zhao, Liang

• Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence

  Gagne, Joshua; Polinski, Jennifer; Jiang, Wenlei; Dutcher, Sarah; Xie, Jing; Lii, Joyce; Fulchino, Lisa; Kesselheim, Aaron

• Role of Authorized Generics in Postapproval Surveillance of Generic Drug Products

  Gagne, Joshua; Sarpatwari, Ameet; Desai, Rishi