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Zdrowie i gospodarka · 21/06/2000

FDA Releases Draft Guidance for Adverse Reactions Section of Prescription Drug Labeling

The Food and Drug Administration (FDA) has published a draft guidance document to improve the content and format of adverse reactions sections in labeling for human prescription drugs and biologics, aiming to minimize the burden on manufacturers and affected parties.

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