Editor's Note Several hundred National Institutes of Health (NIH) employees have issued a rare internal rebuke of the agency’s current leadership under Director Jay Bhattacharya, STAT June 9 reports. The open letter, dubbed the “Bethesda Declaration,” criticizes abrupt Trump-era policy changes, including the cancellation of health equity and LGBTQ+ research,…
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…
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…