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Medicine / Biology / Food and Drug Administration / Drug safety / Pharmacology / Articular cartilage repair / Investigational New Drug / New Drug Application / Investigational Device Exemption / Research / Clinical research / Pharmaceutical industry


SOPP 8002 Appendix 2 - Final Guidance
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City

Rockville / /

Company

A. B. V. / /

Country

United States / /

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Event

FDA Phase / /

Facility

Rockville Pike / /

IndustryTerm

analogous cellular product / concurrent control product / basic manufacturing information / risk devices / final product / cellular products / magnetic resonance imaging / investigational devices / investigational product / gene therapy products / replacement product / human product / manufacturing practices / cellular therapy products / combination product / ultimate clinical product / biological product / particular product / manufacturing / gene therapy product / investigational device / combination products / replacement products / analogous cellular products / cellular and tissue-based products / control product / using the investigational product / /

MedicalCondition

articular cartilage injury / /

MedicalTreatment

Gene Therapy / /

Organization

Biologics Evaluation and Research Center for Devices and Radiological Health / Cellular / Tissue / and Gene Therapies Advisory Committee / office of Communication / Outreach and Development / Food and Drug Administration / Center for Devices and Radiological Health / U.S. Department of Health and Human Services Food and Drug Administration Center / office of Combination Products / Center for Biologics Evaluation and Research / /

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Position

Governor / Forward / /

Product

K90-1 / New Drug / Products Intended / /

ProvinceOrState

Indiana / /

Technology

Gene Therapy / Cell Therapy / CLINICAL STUDY PROTOCOLS / magnetic resonance imaging / MRI / /

URL

http /

SocialTag