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Clinical Chemistry 47: 1743-b, 2001;
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(Clinical Chemistry. 2001;47:1743.)
© 2001 American Association for Clinical Chemistry, Inc.

Letters

Comment on "High-Sensitivity C-Reactive Protein: Product Claims and the Food and Drug Administration"

Marva M. Moxey-Mims1

1 FDA/CDRH/ODE/DCLD Clinical Chemistry Branch 2098 Gaither Rd., HFZ-440 Rockville, MD 20850


To the Editor:

Dr. Ayash’s letter is helpful in trying to clarify the regulatory terminology pertinent to Food and Drug Administration (FDA) marketing applications. It should be pointed out, however, that it is not, and should not be the responsibility of journal reviewers or editors to police the accuracy of claims statements from a regulatory standpoint. The FDA employs compliance officers who monitor advertised claims by manufacturers to ensure that they are consistent with the approved or cleared labeling for their products. Clinicians and researchers are not subject to the same claims restrictions as manufacturers.





This Article
Right arrow Extract Freely available
Right arrow Full Text (PDF)
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the Editor about this paper
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Citing Articles
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Google Scholar
Right arrow Articles by Moxey-Mims, M. M.
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PubMed
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Right arrow Articles by Moxey-Mims, M. M.
Related Collections
Right arrow Lipids, Lipoproteins, and Cardiovascular Risk Factors

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