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The reasons cited by the FDA included concerns about immunogenicity, peptide impurity characterization challenges, and the lack of adequate safety data from human clinical trials

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At the same time, its equally inaccurate to claim that long-term safety has been conclusively established

Prescribers should also be aware that the American Academy of Pediatrics policy statement on off-label prescribing recommends that clinicians "use the best available evidence, inform families clearly about the off-label nature of the treatment, and document the clinical rationale thoroughly" [14]

Laboratories comparing delivery routes for this blend can also review the BPC-157 and TB-500 intranasal spray, supplied pre-mixed with no reconstitution step