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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
US Food and Drug Administration Commissioner Margaret Hamburg outlined last week six initial steps designed to improve the effectiveness and timeliness of FDA's regulatory and enforcement system.
US Food and Drug Administration Commissioner Margaret Hamburg outlined last week six initial steps designed to improve the effectiveness and timeliness of FDA’s regulatory and enforcement system. Hamburg outlined the measures to a group of industry representatives, attorneys, consumers, and others attending a speech sponsored by the Food and Drug Law Institute in Washington DC, and in an agency press release.
Hamburg said that some FDA enforcement actions over the past several years “have been hampered by unreasonable delays” and “in some cases, serious violations have gone unaddressed for far too long.” She added that the pathways for enforcement actions “can be too long and arduous when the public’s health is in jeopardy.” To address these problems, she outlined the following steps to improve FDA’s enforcement activities:
By taking these steps, Hamburg says FDA will ensure that “violative inspection results are taken seriously, that Warning Letters and enforcement actions occur in a timely manner, and that steps are taken to protect consumers in cases where immediate enforcement action is not possible.”