Regulatory evaluation of Glybera in Europe - two committees, one mission

Nat Rev Drug Discov. 2013 Sep;12(9):719. doi: 10.1038/nrd3835-c1. Epub 2013 Aug 19.

Authors

Daniela Melchiorri¹, Luca Pani, Paolo Gasparini, Giulio Cossu, Janis Ancans, John Joseph Borg, Catherine Drai, Piotr Fiedor, Egbert Flory, Ian Hudson, Hubert G Leufkens, Jan Müller-Berghaus, Gopalan Narayanan, Brigitte Neugebauer, Juris Pokrotnieks, Jean-Louis Robert, Tomas Salmonson, Christian K Schneider

Affiliation

¹ Department of Physiology and Pharmacology, the University of Rome "Sapienza", P.le Aldo Moro 5, 00185 Rome, Italy; member of the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA), 7 Westferry Circus, Canary Wharf, London E14 4HB, UK.

PMID: 23954897
DOI: 10.1038/nrd3835-c1

No abstract available

Publication types

Letter

MeSH terms

Cooperative Behavior
Drug Approval / legislation & jurisprudence*
European Union
Genetic Therapy / legislation & jurisprudence*
Humans
Hyperlipoproteinemia Type I / genetics
Hyperlipoproteinemia Type I / therapy*

Grants and funding

MR/K000608/1/MRC_/Medical Research Council/United Kingdom