Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA

OBJECTIVES: US FDA and EMA allow facilitated regulatory pathways to expedite access to new treatments. Limited supportive data may result in major postapproval variations. In Israel, partly relying on Food and Drug Administration (FDA) and European Medicines Agency (EMA), clinical data are reviewed...

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Detalles Bibliográficos
Autores principales: Hiayev, Stephany, Shacham-Shmueli, Einat, Berkovitch, Matitiahu, Weiss, Ilana, Ashkenazi, Shai, Vexberg, Michal Hirsch, Hershkowitz, Rami, Gorelik, Einat, Mayan, Haim, Steinmetz, Yehudit, Yanai, Noa Berar, Schlissel, Orly, Azem, Muhammad, Gutgold, Neriya, Shulman, Katerina, Divinsky, Milly, Yarom, Nirit, Vishkautzan, Alla, Ganzel, Chezi, Gatt, Moshe E, Arcavi, Lidia, Marom, Eli, Uziely, Biatrice, Zevin, Shoshana, Meirow, Hadar, Luxenburg, Osnat, Ainbinder, Denize
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Pharmacology and Therapeutics
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10163499/
https://www.ncbi.nlm.nih.gov/pubmed/37142315
http://dx.doi.org/10.1136/bmjopen-2022-067313

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