Author Topic: FDA questions Novartis' data practices in connection with launching of siponimod (Mayzent)  (Read 14 times)

0 Members and 0 Guests are viewing this topic.

Offline agate

  • Administrator
  • *****
  • Posts: 8134
  • MS diagnosed 1980
  • Location: Pacific Northwest
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 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

Related Topics

  Subject / Started by Replies Last post
19 Replies
344 Views
Last post April 09, 2019, 05:56:37 am
by agate
0 Replies
32 Views
Last post October 19, 2016, 02:53:17 pm
by agate
0 Replies
34 Views
Last post July 21, 2017, 03:21:38 pm
by agate
0 Replies
59 Views
Last post February 06, 2018, 03:42:04 pm
by agate
0 Replies
18 Views
Last post November 30, 2018, 09:18:45 pm
by agate