How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice

BACKGROUND: In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development pla...

Täydet tiedot

Tallennettuna:
Bibliografiset tiedot
Julkaisussa:Br J Clin Pharmacol
Päätekijät: Tafuri, Giovanni, Pagnini, Margherita, Moseley, Jane, Massari, Marco, Petavy, Frank, Behring, Antje, Catalan, Arantxa, Gajraj, Elangovan, Hedberg, Niklas, Obach, Mercè, Osipenko, Leeza, Russo, Pierluigi, Van De Casteele, Marc, Zebedin, Eva‐Maria, Rasi, Guido, Vamvakas, Spiros
Aineistotyyppi: Artigo
Kieli:Inglês
Julkaistu: John Wiley and Sons Inc. 2016
Aiheet:
Clinical Trials
Linkit:https://ncbi.nlm.nih.gov/pmc/articles/PMC5137821/
https://ncbi.nlm.nih.gov/pubmed/27245362
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.13023
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