FDA has announced it is withdrawing 47 draft guidance documents the agency published as far back as 1991 but never finalized because of higher priorities and resource issues. Pursuant to its Good Guidance Practices, FDA typically issues guidance in draft form and solicits public comment before publishing the final version. Noting a heavy workload in recent years due to increased requests by the public for guidance, FDA acknowledged the 47 withdrawn documents had simply become outdated. The action marks an effort by FDA to improve the transparency of its policymaking. In recent times, some federal lawmakers have criticized FDA for "using guidance that appears to create new requirements without the benefit of notice and comment, but with the expectation that the public comply."
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