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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
[15] Serious but infrequent events-such as angioedema, bronchospasm, hypotension, or urticaria-reflect IgE-mediated hypersensitivity and may require desensitization or substitution with hydroxocobalamin
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The FDA placed BPC-157 in Category 2 of the interim 503A bulk-substances list in 2023
