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...

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Foilsithe in:Br J Clin Pharmacol
Main Authors: 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
Formáid: Artigo
Teanga:Inglês
Foilsithe: John Wiley and Sons Inc. 2016
Ábhair:
Clinical Trials
Rochtain Ar Líne: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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