OMB Memo Outlines All FDA Guidance’s Will Be Reviewed by the White House Prior to Publication

From: Policy & Medicine

By Thomas Sullivan

The Trump administration recently issued new guidelines that will expand White House and congressional oversight and review of federal agencies’ rule-making processes, including those for traditionally independent agencies. This will have an especially important impact on the work of the FDA.

Impact on FDA

Generally, FDA releases draft and final guidances to help industry understand the agency’s thinking on a subject. Regulatory Focus notes almost 100 draft guidance documents are intended to be released by just the Center for Drug Evaluation and Research alone. This causes some confusion as to whether the agency regulates based on the non-binding guidance documents.

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