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That classification means the agency has not evaluated it for safety or efficacy in humans through its standard drug approval process, and no manufacturer has completed the preclinical and clinical trial requirements under 21 U.S.C
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Do not assume a recommended addition is necessary for every buyer. Ask how a change to the main order would affect the addition.
Compare alternatives using the same requirements and documented information. Ask whether an apparent feature is included in your selected option.
Ask for clarification if the resolution description remains ambiguous. Retain relevant evidence until you are satisfied the matter is settled.
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