Article, Court Ruling Casts Doubt On FDA’s Use Of Guidance Documents

In a new Legal Backgrounder published by the Washington Legal Foundation, Jeffrey N. Gibbs and Karla L. Palmer write that a recent Florida federal district court ruling in United States v. Franck’s Lab, Inc., if upheld on appeal, will have implications that extend broadly to other areas of FDA law, particularly as it relates to FDA’s increasing use of guidance documents to expand regulatory requirements.