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Glossary Terms

Good Guidance Practice

Documents issued by FDA that explain the agency’s interpretation of, or policy on, a regulatory issue. Primarily for industry, but also for other stakeholders and its own staff, they address such matters as the design, manufacturing, and testing of regulated products; scientific issues; content and evaluation of applications for product approvals; and inspection and enforcement policies. Guidances are not legally binding, but show stakeholders one way to reach their regulatory goal (FDA).

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