Showing results (1-10 of 7) with videos related to
Sort By:
Pageof 1
Alimentary Pharmacology & Therapeutics|May 13, 2021
Review article: the evolution of endpoint assessments for chemotherapy-induced nausea and vomiting and post-operative nausea and vomiting-a perspective from the US Food and Drug AdministrationMaegan E Gabby, Kevin Bugin, Erica LyonsTherapeutic Innovation & Regulatory Science|May 30, 2017
Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA's Role in Ensuring Patient SafetyJonathan P Jarow, Steven Lemery, Kevin Bugin, et al.Journal of Clinical and Translational Science|January 20, 2022
Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output modelKevin Bugin, Gaetano R Lotrecchiano, Michael O'Rourke, et al.Therapeutic Innovation & Regulatory Science|October 26, 2020
New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and ImpactKevin Bugin, Janet Woodcock, Peter Stein, et al.Therapeutic Innovation & Regulatory Science|December 6, 2016
Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year PeriodJonathan P Jarow, Steven Lemery, Kevin Bugin, et al.Therapeutic Innovation & Regulatory Science|November 25, 2020
The Integrated Review: FDA Modernizes the Review of New Drug Marketing ApplicationsRhonda M Hearns-Stewart, John Farley, Kerry Jo Lee, et al.JACC. Advances|February 9, 2025
Embracing Generative Artificial Intelligence in Clinical Research and Beyond: Opportunities, Challenges, and SolutionsHenry P Foote, Chuan Hong, Mohd Anwar, et al.Pageof 1