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Zdrowie i gospodarka · 16/01/2008

FDA Proposes Changes to Labeling of Approved Drugs, Biologics, and Medical Devices

The Food and Drug Administration (FDA) is proposing to update its regulations regarding changes to approved products, allowing for labeling changes only when supported by new evidence, such as contraindications, warnings, or adverse reactions.

Source: Federal Register — Food and Drug AdministrationOpen original release →