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Food and Drug Administration / Biology / Drug discovery / Pharmacology / Drug safety / Pre-clinical development / Investigational New Drug / Cell therapy / New Drug Application / Pharmaceutical sciences / Medicine / Pharmaceutical industry


SOPP 8002 Appendix 2 - Draft Guidance.doc
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City

Rockville / /

Company

Biotechnology-Derived Pharmaceuticals / /

/

Facility

Rockville Pike / /

IndustryTerm

therapeutic biological products / investigational pharmaceutical agent / biological products / cellular products / investigational product / analogous product / combination product / ultimate clinical product / biological product / combination products / certain biologic-device combination products / clinical product / manufacturing processes / analogous cellular products / cellular and tissue-based products / /

MedicalCondition

Disease/Injury / disease / target disease / infection / disease/ injury / infectious disease / /

MedicalTreatment

gene therapy / /

Organization

office of Communication / Outreach and Development / Food and Drug Administration / CBER’s office of Blood Research / U.S. Department of Health and Human Services Food and Drug Administration Center / FDA Center / office of Cellular / office of Combination Products / Center for Drug Evaluation and Research / office of Cellular / Tissue and Gene Therapies / Center for Biologics Evaluation and Research / office of Vaccines Research / /

Person

Tissue Therapies / Gene Therapies / /

/

Position

Governor / general scientific principles / Forward / General / /

ProvinceOrState

Indiana / A. B. / /

Technology

Gene Therapy / CELL THERAPY / drug development / /

URL

http /

SocialTag