FDA Good Guidance Practices
This article was originally published in The Tan Sheet
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
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. |