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Technology / Pharmaceuticals policy / Medical technology / Food law / United States Public Health Service / Medical device / Federal Food / Drug / and Cosmetic Act / Regulatory requirement / In vitro diagnostics / Medicine / Food and Drug Administration / Health


Microsoft Word - CDRH2011111 CompanionDx Final Guidance[removed]docx
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City

Rockville / /

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IndustryTerm

investigational applications / biological products / therapeutic devices / therapeutic product / treatment of metastatic breast cancer / biological product / diagnostic device / appropriate device / in vitro diagnostic device / diagnostic devices / marketing applications / combination product / device products / therapeutic products / diagnostic device manufacturer / drug products / in vitro companion diagnostic device / /

MedicalCondition

gastric cancer / metastatic breast cancer / /

Organization

U.S. Department of Health and Human Services / office of Communication / Outreach and Development / Food and Drug Administration / Division of Dockets Management / Food and Drug Administration Center for Devices / office of Combination Products / Biologics Evaluation and Research Center for Drug Evaluation and Research Contains Nonbinding Recommendations Preface Public Comment You / Drug Evaluation and Research Division of Drug Information / Radiological Health Center for Biologics Evaluation / Center for Drug Evaluation / Center for Biologics Evaluation and Research / /

Person

Elizabeth Mansfield / Silver Spring / /

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Position

Governor / C. General / /

Product

Herceptin / /

ProvinceOrState

Maryland / /

Technology

Diagnostic tests / in vitro diagnostics / /

URL

http /

SocialTag