Safety Labeling Change Order Letters
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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.
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.
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.