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FDA issues final rule on label changes

Device Regulation Alert: Safety, Compliance and Reimbursement News, August 25, 2008

Pharmaceutical and medical device companies can amend the labeling for an approved product without FDA approval but only to reflect newly acquired information, according to new FDA guidance.

Manufacturers can add or strengthen a contraindication, warning, precaution, or adverse reaction only with “sufficient evidence of a causal association” with the product.

According to the FDA, newly acquired information can be derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data, but needs to be of a “different type or greater severity or frequency than previously included in submissions to FDA.”

Eight members of Congress criticized the guidance in a January letter to FDA Commissioner Andrew C. von Eschenbach. They contend the new guidance will “drastically limit the situations in which a manufacturer is permitted” to amend a label without FDA approval. They also said the new guidance sets a higher standard for amending labeling and would “inevitably result in fewer company-initiated warnings.”

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