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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
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

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 - PDF document

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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 - Description

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 Pdf

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Sections 505o3 and 505o4

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