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Medicine / Pharmaceuticals policy / Clinical research / Drug safety / Pharmaceutical industry / Pharmacovigilance / Regulatory requirement / Food and Drug Administration / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Pharmaceutical sciences / Pharmacology / Health


Guidance for Industry E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
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City

Geneva / Rockville / /

Company

Expert Working Group / /

Country

Japan / United States / /

Facility

Rockville Pike / /

IndustryTerm

biological products / medicinal product / authorization applications / medicinal products / marketed medicinal products / /

MedicalCondition

IBD / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / FDA / European Union / Center for Drug Evaluation and Research / Regulatory Authority / ICH Steering Committee / Center for Biologics Evaluation and Research / Council for International Organizations of Medical Sciences / office of Communication / Training / and Manufacturers Assistance / /

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Position

notifying reporter / General / reporter / /

Product

Shure E2c Headphone/Headset / /

ProvinceOrState

Maryland / /

URL

http /

SocialTag