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(120)
• Posters(29)
• Presentations(34)
• Papers(57)

• A General Framework for Assessing IVIVC as a Tool for Maximizing the Benefit-Risk Ratio of a Treatment Using a Convolution-Based Modeling Approach

  Gomeni, Roberto; Fang, Lanyan; Gomeni, Francoise; Spencer, Thomas; Faraone, Stephen; Babiskin, Andrew

• The Association between Patient Sociodemographic Characteristics and Generic Drug Use: A Systematic Review and Meta-Analysis

  Mishuk, Ahmed; Qian, Jingjing; Howard, Jennifer; Harris, Ilene; Frank, Gavriella; Kiptanui, Zippora; Hansen, Richard

• Brand vs Generic Adverse Event Reporting Patterns: An Authorized Generic-Controlled Evaluation of Cardiovascular Medications

  Alatawi, Yasser; Rahman, Mmd Motiur; Cheng, Ning; Qian, Jingjing; Peissig, Peggy; Berg, Richard; Page, David; Hansen, Richard

• Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products

  Chang, Rong-Kun; Raw, Andre; Lionberger, Robert; Yu, Lawrence

• Considerations for Generic-to-Generic Levothyroxine Switching-Reply

  Brito, Juan P; Wang, Zhong; Lipska, Kasia

• 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