You cannot dose the components independently in a pre-mixed blend, which is the main trade-off versus buying them separately
Moreover, the applicant provided that, of the 2.2 million flexible cystoscopy procedures furnished annually, 23 percent are performed with single-use, disposable cystoscopes, further, single-use, disposable cystoscopes are used in at least 500 hospitals and clinics, including 35 to 50 academic medical centers
FDAs 2023 Category 2 placement cited immunogenicity risk for certain routes of administration, peptide-related impurities, complexities in active pharmaceutical ingredient (API) characterization, and limited safety information for the proposed routes
Conclusion: The varied distribution of upper limb weakness when acute interventions are delivered provides a rationale to understand their impact on rehabilitation services and clinical trial site selection
Precision medicine: in need of guidance and surveillance