FDA 21 CFR Part 58
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The challenge
The Food and Drug Administration’s (FDA) standards for Title 21 of the Code of Federal Regulations (CFR), also known as the FDA 21 CFR, provide a clear and concise set of regulations.
A specific approach in FDA 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies, prescribes good laboratory practices (GLP) for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for Food and Drug Administration (FDA)-regulated products.) These include: food and color additives, animal food additives, human and animal drugs, human medical devices, biological products, and electronics.
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