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Firms Have Little Leeway To Change Labels Without Approval, FDA Asserts

This article was originally published in The Gray Sheet

Executive Summary

FDA is reiterating that a drug or device manufacturer may amend product labeling without prior agency approval only if it has "newly acquired" safety information about the product. In addition, the agency says companies may strengthen contraindications and warnings "only if there is sufficient evidence of a causal association with the drug, biologic, or device.
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