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Consumer OTC Drugs

FDA Good Guidance Practices

This article was originally published in The Tan Sheet

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Executive Summary

Agency GGPs codified in Feb. 14 proposed rule. The reg incorporates FDA's 1997 GGP document and FDA Modernization Act provisions addressing guidance development, issuance and use. Legal effect of guidance documents and public participation in guidance development are addressed in the rule, as are dispute resolution and appeal processes
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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