FDA Requests Comments on Safety Labeling Draft Guidance for Drugs and Biologics
The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Safety Labeling Changes - Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.” This draft guidance for certain drugs and biologic…
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products provides information on the implementation of new provisions, including 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. Comments are due by July 12, 2011.