Safety labeling changes draft guidance issued

The FDA would send a safety labeling change notification letter to application holders if a safety labeling change was necessary under a draft guidance published by the agency. Titled “Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act,” the draft document provides information on the implementation of the new provisions, including a description of the types of safety labeling changes that ordinarily might be required, how the 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. In the past, the FDA had requested that holders of applications for approved products make labeling changes related to safety after approval to address serious risks. The FDA learned of the potential for such serious risks from a variety of sources and most application holders responded to the agency’s requests for labeling changes by negotiating appropriate language with the FDA staff to address the concerns and then submitting a supplement or amended supplement to obtain approval of the changes. The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the FDC Act authorizing the FDA to require and, if necessary, order labeling changes if the agency became aware of new safety information that it believed should be included in the labeling of the drug. FDA Notice, ¶42,101

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