Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
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DOI: 10.3389/fmed.2021.716266
Abstract: During the last decade, a plethora of novel therapies containing live microorganisms as active substance(s) has emerged with the aim to treat, prevent, or cure diseases in human beings. Both the Food and Drug Administration… read more here.
Keywords: live biotherapeutic; human clinical; entering first; single strain ... See more keywords