I read an interesting article on the RAPS website this morning about a new initiative set by the FDA to clean-up certain guidance documents. This means finalizing draft guidance documents, withdrawing or updating/revising outdated guidance documents. This initiative is taking place in the Center for Drug Evaluation and Research (CDER) department.

This article explains in more detail the various guidance documents that will be withdrawn as well as the specific guidance document topics that will be revised.

This is an important task because although guidance documents are not regulation, they still can bear the same weight as regulation. For example certain warning letters have made reference to guidance documents as well as draft guidance documents.

Other useful resources to follow this guidance document clean-up initiative include a guidance agenda on the CDER website and regular updates on the CDER website of draft guidances that are under industry review.

I am interested in following the progress of this initiative and seeing how successful it is!

--Jillian F. Walker

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