Johns Hopkins ABX Guide
OpenBiome
INDICATIONS
FDA
FDA
OpenBiome suspended distribution of investigational FMT on December 31, 2024, per final FDA decision.
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.
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Last updated: June 12, 2025
Citation
Dzintars, Kathryn. "OpenBiome." Johns Hopkins ABX Guide, The Johns Hopkins University, 2025. Pediatrics Central, peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540673/5.2/OpenBiome.
Dzintars K. OpenBiome. Johns Hopkins ABX Guide. The Johns Hopkins University; 2025. https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540673/5.2/OpenBiome. Accessed July 18, 2025.
Dzintars, K. (2025). OpenBiome. In Johns Hopkins ABX Guide. The Johns Hopkins University. https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540673/5.2/OpenBiome
Dzintars K. OpenBiome [Internet]. In: Johns Hopkins ABX Guide. The Johns Hopkins University; 2025. [cited 2025 July 18]. Available from: https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540673/5.2/OpenBiome.
* Article titles in AMA citation format should be in sentence-case
TY - ELEC
T1 - OpenBiome
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A1 - Dzintars,Kathryn,PharmD, BCPS
Y1 - 2025/06/12/
BT - Johns Hopkins ABX Guide
UR - https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540673/5.2/OpenBiome
PB - The Johns Hopkins University
DB - Pediatrics Central
DP - Unbound Medicine
ER -
