GUIDANCE DOCUMENT
Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry August 2017
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2017-D-2163
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter for Biologics Evaluation and Research
This guidance is intended to assist applicants, manufacturers, packagers, and distributors (collectively referred to as firms) who choose to include child-resistant packaging (CRP) statements in their drug product labeling. The guidance discusses what information should be included to support CRP statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements to these applications.
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