Entreprise · 28/06/19941 min de lecture
Estrogen Drug Product Labeling; Labeling Guidance Texts; Availability
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Résumé
The Food and Drug Administration (FDA) is announcing the availability of informal labeling guidance texts for professional and patient labeling for estrogen drug products that were last revised in 1992. The texts provide information to assist manufacturers and other persons in preparing supplemental applications to meet labeling requirements. The revisions reflect updated scientific information.