Class-Wide Rx Safety Issues Are Focus Of FDA Guidance On New Label Change Powers
FDA is emphasizing a class-based approach to requiring safety-related drug labeling changes under the FDA Amendments Act.
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Final guidance implementing FDAAA authority explains how disagreements between the agency and one or more sponsors could affect the timeline for safety-related labeling changes across a class of products.
FDA said information about ribavirin-related drug resistance may have an impact on a class of investigational hepatitis C compounds in development but agreed with Merck and Genentech that labeling changes were not warranted “at this time.”
Drug safety labeling changes that cover large classes of drugs are one of the biggest headaches FDA faces, given its new authority in this area under the Food and Drug Amendments Act, which established a new section 505(o) of the Food, Drug and Cosmetic Act.