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Pharmaceutical industry / Clinical research / Pharmacology / Radiobiology / Biodosimetry / Validation / Medical device / Premarket approval / Center for Devices and Radiological Health / Medicine / Health / Food and Drug Administration


Microsoft Word - Guidance (Draft) - Biodosimetry (v7 clean[removed]docx
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City

Rockville / /

Company

In Vitro Diagnostics / Radiological / /

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Event

FDA Phase / /

Facility

Laboratory Standards Institute / /

IndustryTerm

biodosimetry devices / medical management / biological products / throughput and single-use devices / dosimetry devices / radiation biodosimetry devices / dosimetry tools / qualitative devices / diagnostic devices / Radiation biodosimetry tools / improvised nuclear device / protein expression using technology / radiation biodosimetry device / biodosimetry medical countermeasure devices / radiological dispersal device / Radiation biodosimetry technologies / particular device / radiation biodosimetry systems / diagnostic products / Radiation biodosimetry countermeasure devices / premarket approval applications / analytical testing protocols / /

MedicalCondition

disease / patient developing acute radiation syndrome / injury / /

MedicalTreatment

Radiation / /

Organization

Radiological Health Office / U.S. Department of Health and Human Services / Food and Drug Administration / Division of Molecular Genetics and Pathology / Division of Dockets Management / Food and Drug Administration Center for Devices / Clinical and Laboratory Standards Institute / Radiological Health Division of Molecular Genetics and Pathology Devices Contains Nonbinding Recommendations Draft / /

Person

Jennifer Dickey / /

/

Position

Governor / /

Product

Federal Food / /

ProvinceOrState

Maryland / /

Technology

Radiation / protein expression using technology / Radiation biodosimetry technologies / analytical testing protocols / pdf / /

URL

http /

SocialTag