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What Are Some Key Regulatory Guidelines?
The FDA has established various
regulatory guidelines
to ensure the safety of products. These include:
The Code of Federal Regulations (CFR)
: Contains the rules and regulations enforced by the FDA.
Good Laboratory Practice (GLP) Standards
: Guidelines for conducting non-clinical laboratory studies that support research or marketing permits.
Good Manufacturing Practice (GMP) Regulations
: Standards for manufacturing, processing, and packing of drugs and medical devices.
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