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SOPP 8420: FDAAA Section 921: Posting of Potential Signals of Serious Risk Version #1 Effective Date: November 1, 2011 I. Purpose
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Company

AEs / B. CBER FDAAA Safety Working Group / Concur / OBE / CBER Safety Working Group / /

IndustryTerm

public communications / Secondary suspect products / statin products / Internet Web site / web/disclosure clearance / dear healthcare provider notifications / Internet posting requirement / data mining / product-food / product-product / suspect products / therapeutic biologic products / secondary suspect product / Internet postings / healthcare providers / Internet posting / suspect product / using data mining / /

MedicalCondition

product-associated hepatitis / seizures / Stevens Johnson syndrome / hemolytic anemia / patient infection / /

MedicalTreatment

medication errors / /

Organization

DE MOs / DE RPM / World Health Organization / Food and Drug Administration / Division of Epidemiology / Division of Epidemiology Safety Assessment Meetings / office of Biostatistics and Epidemiology / Responsibilities A. CBER Center / A. CBER Center / Center Director C. office of Communication / Outreach / and Development / D. Product office office of Blood Research / OBE Office / office of Cellular / Tissues and Gene Therapies / CBER’s office of Communication / Outreach and Development / office of Cellular / Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / office of Vaccines Research / Product Office / /

Person

Tissues Therapies / Stevens Johnson / Robert A. Yetter / Gene Therapies / /

Position

Director Provides concurrence / project manager for Internet posting d / Clinical Division Director / Team Leader / Director Provides concurrence Office / Clinical Medical Officer / Clinical Review Branch Chief / DE Division Director / Team Leader and the Branch Chief / DE Division Director / Branch Chief / Branch Chief / project manager / Team Project Manager for Internet posting / Clinical Branch Chief / Director Concurs / Director the relevant Product Office Division / the clinical branch chief / Regulatory Project Manager / Center Director / reviewing Medical Officer / Director / manager for preliminary review / Director the DE Division / Director review / Medical Officer / /

Technology

data mining / /

URL

http /

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