![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » FMT Qualifies as Biological Product, Requires IND Filing for Trials: FDA
FMT Qualifies as Biological Product, Requires IND Filing for Trials: FDA
May 27, 2013
The FDA recently informed a group of gastroenterological specialists that fecal microbiota transplantation (FMT), also known as a stool transplant, should be considered a biological product under agency oversight when treating Clostridium difficile (C. difficile) infection.
Clinical Trials Advisor
Clinical Trials Advisor
Upcoming Events
-
21Oct