Sections 505o3 and 505o4 and of the F ederal Food Drug and Cosmetic Act FDCA authorize FDA to require holders of approved drug and biological product applications on the basis of new safety information to conduct postmarketing studies and clinical ID: 35559 Download PdfTags :
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Presentation on theme: "DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silve r Spring MD NDA LABELING SUPPLEMENT AND PMR REQUIRED APPLICANT NAME ADDR ESS Attention CONTACT NAME TITLE Dear CONTACT Pl"— Presentation transcript