Publication:
Comparison of Clinical Evidence Submitted to the FDA and EMA for Cell and Gene Therapies.

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cris.virtualsource.author-orcidecb5b017-b4e6-47f8-947b-8a0f87c9a680
datacite.rightsrestricted
dc.contributor.authorElsallab, Magdi
dc.contributor.authorGillner, Sandra
dc.contributor.authorBourgeois, Florence T
dc.date.accessioned2025-03-12T10:47:41Z
dc.date.available2025-03-12T10:47:41Z
dc.date.issued2025-04
dc.description.abstractThis cross-sectional study compares how sponsors approach parallel submissions of gene and cell therapy applications to drug regulatory agencies.
dc.description.numberOfPages4
dc.description.sponsorshipKPM - Bereich sitem
dc.description.sponsorshipsitem Center for Translational Medicine and Biomedical Entrepreneurship
dc.description.sponsorshipKPM Center for Public Management
dc.identifier.doi10.48620/85891
dc.identifier.pmid39899303
dc.identifier.publisherDOI10.1001/jamainternmed.2024.7569
dc.identifier.urihttps://boris-portal.unibe.ch/handle/20.500.12422/204712
dc.language.isoen
dc.publisherAmerican Medical Association
dc.relation.ispartofJAMA Internal Medicine
dc.relation.issn2168-6114
dc.relation.issn2168-6106
dc.subject.ddc300 - Social sciences, sociology & anthropology::350 - Public administration & military science
dc.subject.ddc600 - Technology::610 - Medicine & health
dc.titleComparison of Clinical Evidence Submitted to the FDA and EMA for Cell and Gene Therapies.
dc.typearticle
dspace.entity.typePublication
dspace.file.typetext
oaire.citation.endPage471
oaire.citation.issue4
oaire.citation.startPage468
oaire.citation.volume185
oairecerif.author.affiliationKPM Center for Public Management
oairecerif.author.affiliation2KPM - Bereich sitem
oairecerif.author.affiliation3sitem Center for Translational Medicine and Biomedical Entrepreneurship
unibe.additional.sponsorshipKPM - Bereich sitem
unibe.additional.sponsorshipsitem Center for Translational Medicine and Biomedical Entrepreneurship
unibe.contributor.roleauthor
unibe.contributor.roleauthor
unibe.contributor.roleauthor
unibe.description.ispublishedpub
unibe.refereedtrue
unibe.subtype.articlejournal

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