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Instead, the FDA cited 'deficiencies in the manufacturing and chemistry documentation (CMC).' This means the issues are related to the paperwork and processes around how the drug is made, rather than how well it works or its side effects in patients

Neuen BL, Young T, Heerspink HJL et al (2019) SGLT2 inhibitors for the prevention of kidney failure in patients with type 2 diabetes: a systematic review and meta-analysis

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