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SUPER: STEP 1: CHECK THE INSULIN Do not use the pen if the insulin is cloudy, colored, or has particles

LC and CF provided constructive opinions on the formation of the manuscript

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This is particularly valuable during early Phase-3 stability studies, when the degradant map is still being drawn

The TGA currently considers the following seven NRAs comparable, based on existing collaboration arrangements: FDA, EMA, Medicines and Healthcare products Regulatory Agency (MHRA, UK), PMDA, Health Canada, Health Sciences Authority (HSA, Singapore), and Swissmedic [30]