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A more recent phase IIb trial evaluated larazotide in 342 celiac patients who did not respond to a gluten-free diet

Yi C, Xia Y, Yan J, Xia W, Wang H, Mao F, et al

G., Hudson J., Cravalho C., Matta S

The FDA Medical Device Approval Process: Pathways, Timelines, and Tips The FDAs medical device approval process is not the same for every device, and the timeline for regulatory approval can vary widely depending on the risk posed by the device