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Clinical research / Food and Drug Administration / Pharmacology / Drug discovery / Investigational Device Exemption / Clinical trial / Good Laboratory Practice / Pre-clinical development / Center for Devices and Radiological Health / Pharmaceutical industry / Pharmaceutical sciences / Research


Attachment B CDRH Draft Guidance Cover Sheet
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City

Rockville / /

Company

Spinal Systems / Dmitriev AE / /

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IndustryTerm

vertebral body augmentation devices / artificial disc devices / stabilization systems / injection site / test protocol / chemical composition / pharmaceutical materials / vertebral body replacement devices / simulated physiologic solution / combination products / intervertebral disc replacement systems / /

MedicalCondition

disease / Fatigue / osteolysis / /

MedicalTreatment

joint replacement / vertebroplasty / joint replacements / /

Organization

International Organization for Standardization / American Society for Testing and Materials / U.S. Department of Health and Human Services / Food and Drug Administration / Radiological Health Orthopedic Spinal Devices Branch Division of General / Division of Dockets Management / Food and Drug Administration Center for Devices / FDA / Neurological Devices Office / Applied Force / /

Person

Investigational Sites / Restorative / Barbara Buch / /

/

Position

Governor / pathologist / OSDB Branch Chief / representative / independent toxicologist / /

ProvinceOrState

Maryland / /

Technology

test protocol / /

URL

http /

SocialTag