AdvaMed, Dems, Public Citizen Share Opposition To Proposed Labeling Rule
This article was originally published in The Gray Sheet
Executive Summary
AdvaMed is siding with Congress and consumer protection groups against a proposed FDA rule governing when a manufacturer can make a labeling change without prior approval from FDA, but the device industry has its own reasons
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FDA Finalizes Labeling Revision Rule; Similar To Controversial Proposal
FDA is sticking with its plan to define when approved medical product labels can be changed without prior authorization from the agency
FDA Finalizes Labeling Revision Rule; Similar To Controversial Proposal
FDA is sticking with its plan to define when approved medical product labels can be changed without prior authorization from the agency
Firms Have Little Leeway To Change Labels Without Approval, FDA Asserts
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.