Search Results - "Bujar, Magda"

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 by Kühler, Thomas Christian, Bujar, Magda, McAuslane, Neil, Liberti, Lawrence

“…ObjectiveTo compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both…”
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An Evaluation of the Swissmedic Regulatory Framework for New Active Substances by Bujar, Magda, Dalla Torre di Sanguinetto, Simon Andreas, Kermad, Adem, Bolte, Claus, McAuslane, Neil

“…Swissmedic is a major regulatory agency that has been benchmarking its timelines for 20 years. To better understand the Swissmedic review times and to examine…”
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A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products among Swissmedic, European Medicines Agency, and US Food and Drug Administration by Rohr, Ulrich-P, Iovino, Mario, Rudofsky, Leonie, Li, Qiyu, Juritz, Stephanie, Gircys, Arunas, Wildner, Oliver, Bujar, Magda, Bolte, Claus, Dalla Torre di Sanguinetto, Simon, Wolfer, Anita

“…Consensus of regulatory decisions on the same Marketing Authorization Application (MAA) are critical for stakeholders. In this context, regulatory decision…”
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Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening by Mashingia, Jane, Ngum, Nancy, Ndomondo-Sigonda, Margareth, Kermad, Adem, Bujar, Magda, Salek, Sam, Walker, Stuart

“…Seven national medicines regulatory authorities in the East African Community (EAC) have embraced regulatory reliance, harmonization and work sharing through…”
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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? by Bujar, Magda, Ferragu, Sara, McAuslane, Neil, Liberti, Lawrence, Kühler, Thomas C.

“…•Regulatory agencies should transparently document their decision-making processes.•We examined if the basis for approved indication could be found in the EMA…”
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Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities by McAuslane, Neil, Bujar, Magda, Sithole, Tariro, Ngum, Nancy, Owusu-Asante, Mercy, Walker, Stuart

“…Background Despite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to…”
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FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines by Liberti, Lawrence, Bujar, Magda, Breckenridge, Alasdair, Hoekman, Jarno, McAuslane, Neil, Stolk, Pieter, Leufkens, Hubert

“…The US Food and Drug Administration (FDA) has four facilitated regulatory pathways (FRPs): Fast Track (FT), Breakthrough Therapy (BTD), Priority Review (PR),…”
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