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FDA Publishes Draft Guidance for Industry on Safety Labeling Changes
FDA has published a draft guidance for industry, “Safety Labeling Changes – Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act,” (PDF) that provides information on the implementation of safety label changes, as well as FDA procedures and enforcement actions. Specifically, as stated in the Federal Register notice, the guidance includes “a description of the types of safety labeling changes that ordinarily might be required under the new legislation, how FDA plans to determine what constitutes new safety information, the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes.” The guidance document was developed to implement section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(o)(4)) which was signed into law by the President on September 27, 2007, as part of the Food and Drug Administration Amendments Act of 2007. The amended law authorizes FDA to require and, if necessary, order labeling changes if FDA becomes aware of new safety information that FDA believes should be included in the labeling of the drug. Further, the law gives FDA new enforcement tools to bring about timely and appropriate safety labeling changes. Comments and suggestions on the guidance document should be submitted by July 12, 2011, by following the instructions in the Federal Register announcement.
