We’ve added a comprehensive FDA Handbook to our website to help you better understand FDA rules, compliance expectations, and industry best practices. Whether you work in healthcare, pharmacy, or regulatory affairs, this guide gives you practical information to help you stay aligned with current FDA standards.
What’s included:
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Administrative guidance
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Notes, records, and documentation
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Regulatory procedures
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Sampling and inspections
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Import guidance
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Recall activities
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Investigations
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Public health collaboration
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Safety practices
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Appendix for reference
The handbook is the Investigations Operations Manual (IOM), which is the FDA’s main guide for how field investigations are performed. The IOM sets the rules that FDA staff follow to ensure investigations are done correctly, consistently, and in support of public health.
