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Once reconstituted, that stability window shrinks to 28 days under refrigeration

doi: 10.1016/j.diabres.2017.01.012 5 SzadkowskaAMadejAZiolkowskaKSzymanskaMJeziornyKMianowskaBet al

This lack of mention is significant, as pharmaceutical companies are required to report all observed and statistically relevant adverse events during clinical trials

However, these findings are preliminary and hypothesis-generating rather than evidence of protective effects in humans

On the clinical research side: CDER reviewed clinical data submissions for more than 150 marketing applications, investigated over 900 complaints related to bioresearch violations, and issued 21 official action indicated (OAI) / Form 483 findings, including instances where companies failed to submit required investigational new drug (IND) applications