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Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
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City

Rockville / /

Company

Expert Working Group / /

Country

Japan / United States / /

Event

FDA Phase / /

Facility

New Hampshire Ave. Bldg. / Rockville Pike / /

IndustryTerm

pharmaceuticals / biotechnology-derived products / pharmaceutical / /

MedicalCondition

serious diseases / cancer / HIV / phototoxicity / chronic toxicity studies / congenital enzyme deficiency diseases / infection / /

Organization

U.S. Department of Health and Human Services / office of Communication / Outreach and Development / Drug Information Center for Drug Evaluation and Research / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / Food and Drug Administration Center for Drug Evaluation / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / European Union / ICH Steering Committee / office of Communications Division / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / /

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Position

General / D. General / /

Product

Chorionic Gonadotropin / United States / /

ProvinceOrState

Maryland / /

Technology

Pharmacokinetics / Tomography / siRNA / biotechnology / Pharmacodynamics / drug development / /

URL

http /

SocialTag