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Full genome sequencing / Genetic testing / Human genome / American Society of Human Genetics / Food and Drug Administration / Genetics / Biology / Genomics


Public Comments FDA’s Draft Guidance: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) The American Society of Human Genetics Submitted 2 February 2015
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Document Date: 2015-02-10 15:14:54

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File Size: 381,42 KB

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City

Dorschner / Rockville / /

Company

Genomic Biobank / /

Facility

Laboratory Developed Tests / /

IndustryTerm

in vitro diagnostic device / diagnostic product / in vitro diagnostic product / confirmatory products / informational services / /

MedicalCondition

JE / /

Organization

American Society of Human Genetics Submitted / FDA / Food and Drug Administration / American Society of Human Genetics / Division of Dockets Management / US Federal Reserve / /

Person

Joseph D. McInerney / /

Position

Executive Vice President / Vice President On behalf of / /

ProvinceOrState

Maryland / Minnesota / /

Technology

genomics / Diagnostic Tests / /

URL

http /

SocialTag