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While systemic injection also delivers peptides to the brain via blood circulation, nasal delivery may provide more direct CNS access for some portion of the dose
FDA's evaluation concluded that the criteria weighed against placement on the list, citing inadequate physicochemical characterization, immunogenicity concerns from impurities and aggregates, lack of clinical effectiveness data for any approved use, and absence of published human exposure data for the proposed subcutaneous and topical routes
Yes, when administered by a trained professional, Vitamin D injections are safe
Under standard review timelines of 6-10 months, regulatory approval could come shortly after
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