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Zdrowie i gospodarka · 22/08/2008

FDA Amends Regulations for Supplemental Applications of Approved Drugs, Biologics, and Medical Devices

The Food and Drug Administration (FDA) has updated its rules to allow for the submission of supplemental applications to modify the labeling of approved medications, biologics, and medical devices, following the discovery of new information that may impact their safety or effectiveness.

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