Author Topic: FDA questions Novartis' data practices in connection with launching of siponimod (Mayzent)  (Read 79 times)

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Offline agate

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From the Regulatory Affairs Professionals Society  (May 6, 2019), an indication that the makers of siponimod (Mayzent) may be hitting a snag. The article is entitled "FDA Raises Concern with Novartis in Clinical Inspection":


https://www.raps.org/news-and-articles/news-articles/2019/5/fda-raises-concerns-with-novartis-in-clinical-insp


Note: RAPS or the Regulatory Affairs Professionals Society seems to be an organization of pharmaceutical industry professionals who are monitoring their own industry--self-regulating.
« Last Edit: May 07, 2019, 08:26:22 am by agate »
MS Speaks--online for 17 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010. Glatopa (glatiramer acetate 40mg 3 times/week) since 12/16/20.

 

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