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The MHRA may consider the active substance, intended purpose, pharmacological action, claims, imagery and wider product presentation

In order to evaluate substantial clinical improvement over currently available treatments to meet the transitional pass-through payment criterion at 419.66(c)(2), we stated that we consider supporting evidence, preferably published peer-reviewed clinical trials, that demonstrates improved clinical outcomes, such as reduction in mortality, complications, subsequent interventions, future hospitalizations, recovery time, pain, or a more rapid beneficial resolution of the disease process comparing the nominated device to the standard of care (88 FR 81733)

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b Changes in the size of dissolved nanocarriers after 6-month storage at 4 C