Fecal microbiota transplantation (FMT) is considered an investigational new drug (IND), which typically requires an application to be filed; however, the FDA has released specific guidance related to these types of therapies.
There's more to see -- the rest of this topic is available only to subscribers.
Last updated: February 1, 2017
Dzintars, Kathryn. "OpenBiome." Johns Hopkins ABX Guide, The Johns Hopkins University, 2017. Johns Hopkins Guides, www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540673/6/OpenBiome.
Dzintars K. OpenBiome. Johns Hopkins ABX Guide. The Johns Hopkins University; 2017. https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540673/6/OpenBiome. Accessed November 29, 2023.
Dzintars, K. (2017). OpenBiome. In Johns Hopkins ABX Guide. The Johns Hopkins University. https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540673/6/OpenBiome
Dzintars K. OpenBiome [Internet]. In: Johns Hopkins ABX Guide. The Johns Hopkins University; 2017. [cited 2023 November 29]. Available from: https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540673/6/OpenBiome.
TY - ELEC
T1 - OpenBiome
ID - 540673
A1 - Dzintars,Kathryn,PharmD, BCPS
Y1 - 2017/02/01/
BT - Johns Hopkins ABX Guide
UR - https://www.hopkinsguides.com/hopkins/view/Johns_Hopkins_ABX_Guide/540673/6/OpenBiome
PB - The Johns Hopkins University
DB - Johns Hopkins Guides
DP - Unbound Medicine