1349P A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products between Swissmedic, EMA and FDA

U-P Rohr,M Iovino,L Rudofsky,Q Li,S Juritz,A Gircys,O Wildner,M Bujar,S Dalla-Torre,A Wolfer

doi:10.1016/j.annonc.2022.07.1481

1349P A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products between Swissmedic, EMA and FDA

U-P Rohr, M Iovino + Show 8 more

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https://doi.org/10.1016/j.annonc.2022.07.1481

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Journal: Annals of oncology : official journal of the European Society for Medical Oncology	Publication Date: Sep 1, 2022
License type: publisher-specific-oa

Affiliation: Swissmedic, Centre for Innovation in Regulatory Science

#European Medicines Agency #Food & Drug Administration + Show 8 more

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Abstract

Consensus of regulat. decisions on the same Marketing Authorization Application (MAA) are critical for many stakeholders. Regulat. decision patterns from Swissmedic (SMC), US Food & Drug Administration (FDA) and European Medicines Agency (EMA) were analysed separately for hemato-oncology products (OP) and non-oncology products (NOP).

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