Magda Bujar

FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines

Lawrence Liberti, Magda Bujar, Alasdair Breckenridge et al. · Frontiers in Pharmacology · 2017 · 33 citations · Full text

Pharmacy, Pharmaceutical Policy, Drug Approval Processes +13

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

Ulrich‐P. Rohr, Mario Iovino, Leonie Rudofsky et al. · Clinical and Translational Science · 2023 · 18 citations · Full text

Pharmacy, Oncology, Pharmaceutical Policy +16

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

Thomas C. Kühler, Magda Bujar, Neil McAuslane et al. · BMJ Open · 2019 · 15 citations · Full text

Pharmacy, Pharmaceutical Policy, Drug Approval Processes +15

Regulatory performance of the East African Community joint assessment procedure: The way forward for regulatory systems strengthening

Jane Mashingia, Nancy Ngum, Margareth Ndomondo-Sigonda et al. · Regulatory Toxicology and Pharmacology · 2023 · 13 citations · Full text

Pharmacy, Pharmaceutical Policy, Regulatory Policy +17