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Fourth, while the applicant asserted that the FDA News Release (2021, April 1) encouraged manufacturers to transition to single-use, disposable devices, we noted that this FDA News Release does not specifically reference single-use, disposable cystoscopes but, rather encouraged manufacturers to transition to devices with features that eliminate the need for reprocessing and provided information to manufacturers on how to modify and validate their reprocessing instructions

Over a 28-day period, lean WT mice treated with either compound exhibited increased body weight, replicating results seen in the shorter 14-day study