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

OBJECTIVE: To compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016. DESIGN: Using publicly available information from FDA and EMA websites, new active substances (NASs)...

Celý popis

Uloženo v:
Podrobná bibliografie
Vydáno v:BMJ Open
Hlavní autoři: Kühler, Thomas Christian, Bujar, Magda, McAuslane, Neil, Liberti, Lawrence
Médium: Artigo
Jazyk:Inglês
Vydáno: BMJ Publishing Group 2019
Témata:
Public Health
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC6887045/
https://ncbi.nlm.nih.gov/pubmed/31772082
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmjopen-2018-028677
Tagy: Přidat tag
Žádné tagy, Buďte první, kdo otaguje tento záznam!

Podobné jednotky