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[2] However, pursuant to FDA Guidance Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (Jan 2018), 503(a) and 503(b) facilities may still mix, dilute or repackage

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Publisher: Cell Press

Nuthakki VK, et al

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Even though these side effects are generally mild and short-lived, its essential to monitor and seek medical attention if any concerns arise