Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development.
Fiche publication
Date publication
août 2019
Journal
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
Auteurs
Membres identifiés du Cancéropôle Est :
Pr PEYRIN-BIROULET Laurent
Tous les auteurs :
Reinisch W, Gottlieb K, Colombel JF, Danese S, Panaccione R, Panes J, Peyrin-Biroulet L, Rubin D, Sands BE, Schreiber S, Vermeire S, Mulberg A, Sandborn B
Lien Pubmed
Résumé
In 2016, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) released revised EMA and new FDA draft guidelines related to the development of drugs intended for the treatment of ulcerative colitis. We sought to compare and contrast the EMA draft guideline with the FDA draft guidance to facilitate further discussion and perhaps harmonization between the 2 guidelines when they are finalized.
Mots clés
Drug Development, EMA, FDA, Guidelines, Inflammatory Bowel Disease, Ulcerative Colitis
Référence
Clin. Gastroenterol. Hepatol.. 2019 Aug;17(9):1673-1679.e1