GDUFA Research Outcomes

Data & 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(125)
• Posters(29)
• Presentations(37)
• Papers(59)

• Prevalence and Predictors of Generic Drug Skepticism among Physicians: Results of a National Survey

  Kesselheim, Aaron; Gagne, Joshua; Eddings, Wesley; Franklin, Jessica; Ross, Kathryn; Fulchino, Lisa; Campbell, Eric

• Provider and Patient Determinants of Generic Levothyroxine Prescribing: An Electronic Health Records-Based Study

  Romanelli, Robert; Nimbal, Vani; Dutcher, Sarah; Pu, Xia; Segal, Jodi

• Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics

  Woo, Jason; Luan, Jingyu; Li, Zili.; Grosser, Stella; Peters, John; Chazin, Howard

• 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

• 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

• 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

• 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