Comparison of the EMA and FDA Guidelines on Ulcerative Colitis Drug Development

Author:

Reinisch Walter,Gottlieb Klaus,Colombel Jean-Frederic,Danese Silvio,Panaccione Remo,Panes Julian,Peyrin-Biroulet Laurent,Rubin David,Sands Bruce E.,Schreiber Stefan,Vermeire Severine,Mulberg Andrew,Sandborn Bill

Publisher

Elsevier BV

Subject

Gastroenterology,Hepatology

Reference19 articles.

1. Ulcerative colitis: clinical trial endpoints guidance for industry. Draft guidance. Report no. 15028dft.doc 07/27/16 UCM515143,2016

2. European Medicines Agency. Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis. CHMP/EWP/18463/2006 Rev.1. Available from: https://www.ema.europa.eu/documents/scientific-guideline/guideline-development-new-medicinal-products-treatment-ulcerative-colitis-revision-1_en.pdf. Accessed June 28, 2018.

3. Development of an index to define overall disease severity in IBD;Siegel;Gut,2018

4. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 1: definitions and diagnosis;Dignass;J Crohn's Colitis,2012

5. A critical assessment of composite and coprimary endpoints: a complex problem;Buzney;J Am Acad Dermatol,2008

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