France's New Framework for Regulating Off-Label Drug Use

Autor:	Annie Lorence, Joseph Emmerich, Nathalie Dumarcet
Rok vydání:	2012
Předmět:	Decree Drug Drug-Related Side Effects and Adverse Reactions business.industry media_common.quotation_subject MEDLINE Off-Label Use General Medicine Pharmacology Public administration Off-label use Government regulation Government Regulation Medicine France business Drug Approval media_common
Zdroj:	New England Journal of Medicine. 367:1279-1281
ISSN:	1533-4406 0028-4793
Popis:	A new French law aimed at strengthening drug safety and a related decree regarding “Temporary Recommendations for Use” provide a regulatory process for temporarily supervising the prescribing of drugs for indications for which they are not yet licensed.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d43c3c8dbddbbf6c0c5792a2ca903b1c https://doi.org/10.1056/nejmp1208347 Zobrazit plný text záznamu