Module 1 2021

Code of Federal Regulations (CFR- e-CFR) Organization and Content • Title − Broad subject area of an Agency  Title 21 (Food and Drugs) • Part − Rules on a single program or function, e.g.,  Part 312 (Investigational New Drug Application) • Section − Basic unit of the CFR  312.32 (IND Safety Reports) • Paragraph − Specific Requirements  312.32(c)(2) (Telephone and facsimile transmission safety reports)

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TACTICAL CONSIDERATIONS

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