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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

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Since CGS catalyzes the conversion of Cys to cystathionine, its absence would be expected to increase Cys levels, which in turn could increase its availability for GSH biosynthesis

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Occasional vomiting , typically associated with rapid dose escalation