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21 CFR 211.100(a) FDA cited 21 CFR 211.100(a) for failure to establish adequate written procedures for production and process control most frequently: 38 times across the 94 inspection-based warning letters reviewed

What they found (summary): Amylin is a critical partner of insulin in metabolism, the loss of amylin in T2DM is as significant as the loss of insulin The AMY1 receptor in the area postrema is the primary target for the appetite effect Amyloid aggregation is the main problem with native amylin, proline substitutions (the Pramlintide strategy) are essential The half-life of native amylin is only 13 minutes, that is why lipidated analogs like Cagrilintide are necessary Perspective: amylin + GLP-1 combinations are the natural evolution of metabolic pharmacotherapy Why it matters: This is the reference article for amylin pharmacology