Kevin Bugin
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View article: Trends in COVID-19 therapeutic clinical trials
Trends in COVID-19 therapeutic clinical trials Open
View article: Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output model
Evaluating integration in collaborative cross-disciplinary FDA new drug reviews using an input-process-output model Open
Background/Objectives: The US Food and Drug Administration (FDA) is responsible for assessing safety (risks) and effectiveness (benefits) of new drug products using the data provided in a Sponsor’s new drug product marketing application be…
View article: Correction to: The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications
Correction to: The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications Open
View article: New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact
New Drugs Regulatory Program Modernization: Vision, Strategic Objectives, and Impact Open
View article: Modelling Cross-disciplinary Integration in FDA Multidisciplinary and Interdisciplinary Reviews for New Drug Products: A Phenomenological Descriptive Comparative Case Study
Modelling Cross-disciplinary Integration in FDA Multidisciplinary and Interdisciplinary Reviews for New Drug Products: A Phenomenological Descriptive Comparative Case Study Open
Cross-disciplinary integration is a key feature of interdisciplinary research and the collaborative form is often one of the desired outcomes of Team Science endeavors. In 2019 the FDA began rolling out a new interdisciplinary approach to …
View article: Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety
Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety Open
View article: Development of Celiac Disease Therapeutics: Report of the Third Gastroenterology Regulatory Endpoints and Advancement of Therapeutics Workshop
Development of Celiac Disease Therapeutics: Report of the Third Gastroenterology Regulatory Endpoints and Advancement of Therapeutics Workshop Open