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Magda Bujar
Magda Bujar
Medicine
food and drug administration
Documentation
Pharmacology
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4
Papers
45
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Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From Public Assessment Reports?
2021
Clinical Therapeutics
Magda Bujar
Sara Ferragu
Neil McAuslane
Lawrence Liberti
Thomas C. Kühler
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Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice.
2020
Therapeutic Innovation & Regulatory Science
Celine Rodier
Magda Bujar
Neil McAuslane
Prisha Patel
Lawrence Liberti
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To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016
2019
BMJ Open
Thomas Christian Kühler
Magda Bujar
Neil McAuslane
Lawrence Liberti
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FDA Facilitated Regulatory Pathways : Visualizing Their Characteristics, Development, and Authorization Timelines
2017
Frontiers in Pharmacology
Lawrence Liberti
Magda Bujar
Alasdair Breckenridge
Jarno Hoekman
Neil McAuslane
Pieter Stolk
Hubert G. M. Leufkens
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Citations (37)
1