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Zdrowie i gospodarka · 29/07/2020

FDA Releases Draft Guidance on Setting Endotoxin Limits for Investigational Oncology Drugs and Biological Products

The US Food and Drug Administration (FDA) has published a draft guidance document outlining its recommendations for setting endotoxin limits in investigational oncology drugs and biological products, aiming to balance patient safety with the potential benefits of these treatments for serious and life-threatening diseases.

Source: Federal Register — Food and Drug AdministrationOpen original release →