FDA TO ENFORCE PEDIATRIC LABELING REQUIREMENT THROUGH MISBRANDING COURT CASES, AGENCY SAYS; SPONSORS TO HAVE 21 MONTHS TO BRING PRODUCTS INTO COMPLIANCE
Executive Summary
FDA plans to enforce its mandatory pediatric labeling rule by invoking the FD&C Act requirements that labeling take into account "customary" or "suggested" uses, the agency explained in a proposed rule published in the Aug. 15 Federal Register.
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