EMEA and the evaluation of health-related quality of life data in the drug regulatory process.
Papanicolaou
Sotiria
S
Eli Lilly and Company Limited, Windlesham, Surrey, UK.
Sykes
David
D
Mossialos
Elias
E
D002986:Clinical Trials as Topic / Q000592:standards*; D017277:Drug Approval; D015507:Drugs, Investigational / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D006304:Health Status; D006801:Humans; D007390:International Agencies; D017063:Outcome Assessment, Health Care / Q000592:standards*; D011788:Quality of Life / Q000331:legislation & jurisprudence*
D015507:Drugs, Investigational