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FDA announced the final ruling on new, more stringent packaging and warning label requirements for OTC pain relievers and fever reducers containing acetaminophen and NSAIDs at a briefing. Internal analgesics, antipyretics and antirheumatic drug products are all affected by this ruling. Matthew Holman, PhD, Deputy Director, Division of Nonprescription Regulation Development, Office of Nonprescription Products, Office of New Drugs, Center for Drug Evaluation and Research, FDA; and Charles Ganley, MD, Director, Office of Nonprescription Products, Office of New Drugs, CDER, FDA, addressed press questions and spelled out the requirements, which were originally stated in December 2006.

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