{"id":"https://openalex.org/W4295828575","doi":"https://doi.org/10.1016/j.annonc.2022.07.1481","title":"1349P A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products between Swissmedic, EMA and FDA","display_name":"1349P A decade comparison of regulatory decision patterns for oncology products to all other non-oncology products between Swissmedic, EMA and FDA","publication_year":2022,"publication_date":"2022-09-01","ids":{"openalex":"https://openalex.org/W4295828575","doi":"https://doi.org/10.1016/j.annonc.2022.07.1481"},"language":"en","primary_location":{"id":"doi:10.1016/j.annonc.2022.07.1481","doi":"https://doi.org/10.1016/j.annonc.2022.07.1481","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.annonc.2022.07.1481","pdf_url":"https://www.annalsofoncology.org/article/S0923-7534(22)03332-4/pdf","source":{"id":"https://openalex.org/S41454044","display_name":"Annals of Oncology","issn_l":"0923-7534","issn":["0923-7534","1569-8041"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Annals of Oncology","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"bronze","oa_url":"https://www.annalsofoncology.org/article/S0923-7534(22)03332-4/pdf","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5050343801","display_name":"U-P. Rohr","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"U-P. Rohr","raw_affiliation_strings":["Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5055652952","display_name":"Mario Iovino","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"M. Iovino","raw_affiliation_strings":["Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5090089105","display_name":"Leonie Rudofsky","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"L. Rudofsky","raw_affiliation_strings":["Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5057185053","display_name":"Q. Li","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Q. Li","raw_affiliation_strings":["Biostatistics, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Biostatistics, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5026161558","display_name":"Stephanie Juritz","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"S. Juritz","raw_affiliation_strings":["Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5011835309","display_name":"Ar\u016bnas Gir\u010dys","orcid":"https://orcid.org/0009-0003-6417-3066","observed_orcids":["https://orcid.org/0009-0003-6417-3066"]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"A. Gircys","raw_affiliation_strings":["Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5010766062","display_name":"O. Wildner","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"O. Wildner","raw_affiliation_strings":["Arzneimittelsicherheit, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Arzneimittelsicherheit, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5067931491","display_name":"M. Bujar","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210096807","display_name":"Centre for Innovation in Regulatory Science","ror":"https://ror.org/00v71jq68","country_code":"GB","type":"other","lineage":["https://openalex.org/I4210096807"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"M. Bujar","raw_affiliation_strings":["Strategic Development, Centre for Innovation in Regulatory Science, London, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Strategic Development, Centre for Innovation in Regulatory Science, London, UK","institution_ids":["https://openalex.org/I4210096807"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015818525","display_name":"Simon Dalla Torre di Sanguinetto","orcid":"https://orcid.org/0000-0002-0808-4638","observed_orcids":["https://orcid.org/0000-0002-0808-4638"]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"S. Dalla-Torre","raw_affiliation_strings":["Zulassung, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Zulassung, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5087410046","display_name":"A. Wolfer","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1325311562","display_name":"Swissmedic","ror":"https://ror.org/03hdjmh87","country_code":"CH","type":"government","lineage":["https://openalex.org/I1325311562"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"A. Wolfer","raw_affiliation_strings":["Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Assessment, Swissmedic Swiss Agency for Therapeutic Products, Bern, Switzerland","institution_ids":["https://openalex.org/I1325311562"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":{"value":4230,"currency":"USD","value_usd":4230},"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"33","issue":null,"first_page":"S1156","last_page":"S1156"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.3555000126361847,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T11792","display_name":"Pharmaceutical Economics and Policy","score":0.3555000126361847,"subfield":{"id":"https://openalex.org/subfields/2002","display_name":"Economics and Econometrics"},"field":{"id":"https://openalex.org/fields/20","display_name":"Economics, Econometrics and Finance"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T14396","display_name":"Healthcare Regulation","score":0.31839999556541443,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.10540000349283218,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/oncohematology","display_name":"oncohematology","score":0.824999988079071},{"id":"https://openalex.org/keywords/marketing-authorization-applications","display_name":"marketing authorization applications","score":0.8119999766349792},{"id":"https://openalex.org/keywords/swissmedic","display_name":"Swissmedic","score":0.9459999799728394},{"id":"https://openalex.org/keywords/ema","display_name":"EMA","score":0.8309999704360962},{"id":"https://openalex.org/keywords/fda","display_name":"FDA","score":0.9959999918937683},{"id":"https://openalex.org/keywords/regulatory-consensus","display_name":"regulatory consensus","score":0.6679999828338623},{"id":"https://openalex.org/keywords/drug-approval","display_name":"drug approval","score":0.6380000114440918}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7873589992523193},{"id":"https://openalex.org/C159023312","wikidata":"https://www.wikidata.org/wiki/Q409513","display_name":"NOP","level":3,"score":0.6798787713050842},{"id":"https://openalex.org/C2779343474","wikidata":"https://www.wikidata.org/wiki/Q3109175","display_name":"Context (archaeology)","level":2,"score":0.6640341281890869},{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.515656590461731},{"id":"https://openalex.org/C2778917124","wikidata":"https://www.wikidata.org/wiki/Q7309705","display_name":"Regulatory science","level":2,"score":0.4530775249004364},{"id":"https://openalex.org/C108759981","wikidata":"https://www.wikidata.org/wiki/Q788590","display_name":"Authorization","level":2,"score":0.42172881960868835},{"id":"https://openalex.org/C2992293740","wikidata":"https://www.wikidata.org/wiki/Q4781752","display_name":"Drug approval","level":3,"score":0.4115937352180481},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.3325563073158264},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.2155446708202362},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.18693649768829346},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.08520647883415222},{"id":"https://openalex.org/C38652104","wikidata":"https://www.wikidata.org/wiki/Q3510521","display_name":"Computer security","level":1,"score":0.0},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.0},{"id":"https://openalex.org/C170493617","wikidata":"https://www.wikidata.org/wiki/Q208467","display_name":"Receptor","level":2,"score":0.0},{"id":"https://openalex.org/C151730666","wikidata":"https://www.wikidata.org/wiki/Q7205","display_name":"Paleontology","level":1,"score":0.0},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1016/j.annonc.2022.07.1481","doi":"https://doi.org/10.1016/j.annonc.2022.07.1481","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.annonc.2022.07.1481","pdf_url":"https://www.annalsofoncology.org/article/S0923-7534(22)03332-4/pdf","source":{"id":"https://openalex.org/S41454044","display_name":"Annals of Oncology","issn_l":"0923-7534","issn":["0923-7534","1569-8041"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Annals of Oncology","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.1016/j.annonc.2022.07.1481","doi":"https://doi.org/10.1016/j.annonc.2022.07.1481","is_oa":true,"landing_page_url":"https://doi.org/10.1016/j.annonc.2022.07.1481","pdf_url":"https://www.annalsofoncology.org/article/S0923-7534(22)03332-4/pdf","source":{"id":"https://openalex.org/S41454044","display_name":"Annals of Oncology","issn_l":"0923-7534","issn":["0923-7534","1569-8041"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-3","medline","norway-2","poland-200","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320990","host_organization_name":"Elsevier BV","host_organization_lineage":["https://openalex.org/P4310320990"],"host_organization_lineage_names":["Elsevier BV"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Annals of Oncology","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.8048999905586243,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[{"id":"https://openalex.org/F4320314178","display_name":"European Federation of Pharmaceutical Industries and Associations","ror":"https://ror.org/00g1x4v36"}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4295828575.pdf","grobid_xml":"https://content.openalex.org/works/W4295828575.grobid-xml"},"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4383301890","https://openalex.org/W2800436295","https://openalex.org/W7125274706","https://openalex.org/W2474212275","https://openalex.org/W2401695302","https://openalex.org/W2794369493","https://openalex.org/W3210056441","https://openalex.org/W1989308735","https://openalex.org/W4379645171","https://openalex.org/W2892335150"],"abstract_inverted_index":null,"counts_by_year":[],"updated_date":"2026-10-27T15:51:10.671819","created_date":"2022-09-15T00:00:00"}
