Tag: Biopharma
AAMI updates guidelines on radiation sterilization validation, single-use systems control
Editor's Note In a new guidance document for manufacturers of pharmaceuticals and biopharmaceuticals, The Association for the Advancement of Medical Instrumentation (AAMI) has released a new guidance document updating best practices for radiation sterilization validation and routine control of single-use systems. The document, AAMI CR513:2024; Guidance on radiation sterilization validation and…
Supply chain expert warns that drug shortages will persist
Editor's Note Vials of the chemotherapy drug fludarabine could be purchased at a whole sale price of $110 last year—today, it is being sold for a much higher price, Fierce Pharma November 1 reports. One company, Areva Pharmeceuticals, increased the price to $2,736, Stat News reported on October 27. This…
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