GDUFA Research Outcomes

Post-Approval Monitoring

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to post-approval monitoring of generic products.

• All(91)
• Posters(30)
• Presentations(12)
• Papers(49)

• Switch-Backs 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

• Estimating Generic Drug Use with Electronic Health Records Data from a Health Care Delivery System: Implications for Quality Improvement Research

  Nimbal, Vani; Segal, Jodi; Romanelli, Robert

• 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

• 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

• 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

• 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

• 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