The discovery of a contaminant in batches of heparin throws into stark relief the difficulties, not only for the US Food and Drug Administration, but also for international regulatory agencies, to ensure the safety and quality of active pharmaceutical ingredients.
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Laurencin, C., Nair, L. The FDA and safety—beyond the heparin crisis. Nat Biotechnol 26, 621–623 (2008). https://doi.org/10.1038/nbt0608-621
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DOI: https://doi.org/10.1038/nbt0608-621