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1 The original plan was a six-month pilot through the end of 2026, after which BALANCE would take over and shift the cost from the federal government to the Part D plans

Conversely, economic downturns can lead to budgetary constraints in healthcare systems and potentially limit patient access, especially in countries with less robust reimbursement mechanisms

Key characteristics of 503B outsourcing facilities: FDA registration and inspection: 503B facilities must register with the FDA and are subject to regular FDA inspections using current Good Manufacturing Practice (cGMP) standards - the same framework used to inspect conventional drug manufacturers

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