With New Power, New Problems: FDA Confronts Complications of Safety Labeling Change Authority
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.
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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.
Misclassifying adverse events and adverse reactions is a major source of error on drug labels, Leander Fontaine, former head of labeling at Wyeth, said.
Seeking to turn the regulatory burdens imposed by the FDA Amendments Act to their advantage, pharmaceutical manufacturers are asking the agency to give sponsors the power to trigger safety-related labeling changes under the statute.