Hyman Phelps and McNamara
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Court Ruling Casts Doubt On FDA's Use Of Guidance Documents
December 16, 2011

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.

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If you have any questions regarding the above information, please contact:
Jeffrey N. Gibbs (202) 737-4288 jgibbs@hpm.com
Karla L. Palmer (202) 737-7542 kpalmer@hpm.com