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Compounding and the FDA: Questions & Answers

Arakawa M, Mita T, Azuma K, Ebato C, Goto H, Nomiyama T, Fujitani Y, Hirose T, Kawamori R, Watada H: Inhibition of monocyte adhesion to endothelial cells and attenuation of atherosclerotic lesion by a glucagon-like peptide-1 receptor agonist, exendin-4

Because these compounds are naturally occurring peptides with restricted patentability, opportunities for intellectual property protection and industry-sponsored development are limitedposing substantial barriers to the resource-intensive clinical investigations required to confirm therapeutic efficacy and long-term safety

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doi: 10.1016/j.biopha.2018.08.088 142 SheikhA

The US study reported a tendency towards decreasing risks for prostate cancer with increasing duration of GLP-1RA use [3]