Analysis Life Sciences Thank You The U.S. regulatory landscape for probiotics and other microbiome-based therapies
Agency IQ
NOVEMBER 3, 2023
Although this guidance document is mostly focused on chemistry, manufacturing and control (CMC) information, it clarifies that LBPs are considered biologics, and will thus need to utilize the Biologics License Application (BLA) pathway. The regulation of dietary supplements in the U.S.
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