Meeting with CBER. On May 22, ISAPP’s Executive Science Officer (Mary Ellen Sanders) and Daniel Merenstein MD (Georgetown University) met with Peter Marks MD PhD, Deputy Director of Center for Biologics Evaluation and Research/FDA, and three other CBER representatives, to discuss CBER oversight of probiotic research as investigational new drugs. Concerns were expressed regarding requiring phase 1 safety studies, the lack of a waiver option, and inhibition of investigator-initiated studies. The meeting was a productive beginning to these discussions. Report.
https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png 0 0 Mary Ellen Sanders https://isappscience.org/wp-content/uploads/2021/06/ISAPP_LogoRedsign_horz.png Mary Ellen Sanders2014-06-05 00:00:002019-04-18 16:05:23June 5, 2014