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If it is approved, Ryan said it will be important to monitor the drug for safety in the real-world population during the postmarketing surveillance period, as real-world populations differ from people enrolled in a clinical trial

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Pharmacopeia guidelines typically impose a 28-day limit for opened multi-dose injectables to minimize contamination and stability issues

At present, no Good Manufacturing Practice (GMP)-compliant production pipeline has been formally established for PDEVs