New FDA communication introduces a more flexible, risk‑based chemistry, manufacturing, and controls (CMC) framework for cell and gene therapies, including phased data submission to support earlier ...
Elemental impurity risk management can help biomanufacturers to maintain regulatory alignment and ensure patient safety.
The field of industrial hygiene (IH) is evolving. As Baby Boomers retire and long-held IH roles are increasingly being restructured, outsourced, or integrated into broader OH&S programs, many ...
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