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)

• Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

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

• Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval

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

• Comparative Effectiveness of Generic and Brand-Name Medication Use: A Database Study of US Health Insurance Claims

  Desai, Rishi; Sarpatwari, Ameet; Dejene, Sara; Khan, Nazleen; Lii, Joyce; Rogers, James; Dutcher, Sarah; Raofi, Saeid; Bohn, Justin; Connolly, John; Fischer, Michael; Kesselheim, Aaron; Gagne, Joshua

• Influencers of Generic Drug Utilization: A Systematic Review

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

• The Need for Deliberate and Thorough Design and Critique of Observational Comparative Effectiveness Research

  Pham, Phuong

• Analyses of Marketplace Tacrolimus Drug Product Quality: Bioactivity, NMR and LC-MS

  Sommers, Cynthia; Pang, Eric; Ghasriani, Houman; Berendt, Robert; Vilker, Vincent; Keire, David; Boyne II, Michael

• Generic Levothyroxine Initiation and Substitution among Medicare and Medicaid Populations: A New User Cohort Study

  Huo, Nan; Chen, Li; Mishuk, Ahmed; Li, Chao; Hansen, Richard; Harris, Ilene; Kiptanui, Zippora; Wang, Zhong; Dutcher, Sarah; Qian, Jingjing

• Evaluating the Clinical Impact of Formulation Variability: A Metoprolol Extended-Release Case Study

  Kim, Sarah; Sharma, Vishnu; Lingineni, Karthik; Farhan, Nashid; Fang, Lanyan; Zhao, Liang; Brown, Joshua; Cristofoletti, Rodrigo; Vozmediano, Valvanera; Ait Oudhia, Sihem; Lesko, Lawrence; Trame, Mirjam; Schmidt, Stephan

• Mixed Approach Retrospective Analyses of Suicide and Suicidal Ideation for Brand Compared with Generic Central Nervous System Drugs

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

• Comparison Of Outcomes Following A Switch From A Brand To An Authorized Vs. Independent Generic Drug

  Hansen, Richard; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane-Vazquez, Enrique; Enrique; Dutcher, Sarah; Raofi, Saeid; Page, David; Peissig, Peggy