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Guidance on use of "FDA approved" label claim forthcoming -- agency's Williams.

This article was originally published in The Tan Sheet

Executive Summary

"FDA APPROVED" LABELING CLAIM GUIDANCE FORTHCOMING, FDA Division of Drug Labeling and OTC Compliance Director Bradford Williams told attendees at the Nonprescription Drug Manufacturers Association annual regulatory/marketing seminar in East Rutherford, N.J. March 11-12. The FDA Modernization Act (FDAMA) includes language in Section 421 that strikes a rule prohibiting drug marketers from making claims their products are approved by FDA. "Guidance will be forthcoming on this," Williams noted.
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