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Title 21 CFR, Parts 1-99, includes rules, regulations, procedures and administrative procedures associated with the Food and Drug Administration and the Department of Health and Human Services (administrative practices, electronic records, public hearings), environmental impact considerations, pharmaceutical good manufacturing practice reports, medical device quality system audit reports/device product evaluation reports (in the United States and European community), protection of human subjects, financial disclosure by clinical investigators, good laboratory practice, patent term restoration, color additives, and more.

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