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Next Generation Therapeutics

The Regulatory Environment of Microbiome-Based Therapies in the US and EU - WHITEPAPER


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The advancement of live microbiome therapies into later phase clinical trials has raised hopes of a near-future where we will be able to prevent or treat diseases by modulating the microbiome. While new companies are joining the microbiome industry each year, there is one barrier of entry that makes life in the industry as difficult as one can expect in an emerging field: regulatory uncertainty. This whitepaper reviews the current situation in two parts of the world where the microbiome industry is advancing fast, namely the US and the EU.

It looks at two case studies: the uncertain status of fecal microbiota transplantation (FMT) in the US and  FMT under Gene, Cells, and Tissue Regulations in Europe.

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