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Clinical research / FDA Fast Track Development Program / Center for Drug Evaluation and Research / Title 21 of the Code of Federal Regulations / Surrogate endpoint / Criticism of the Food and Drug Administration / New Drug Application / Medicine / Food and Drug Administration / Health


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City

Rockville / /

Company

Clinical Studies / /

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Event

FDA Phase / Product Issues / Product Recall / /

Facility

Rockville Pike / /

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IndustryTerm

biological products / treatment of serious or life-threatening diseases / guidance Web page / /

MedicalCondition

tumor / recognized disease / disease / metastatic non-small cell lung cancer / diseases / /

Organization

U.S. Department of Health and Human Services / office of Communication / Outreach / and Development / Food and Drug Administration Center for Drug Evaluation and Research / office of New Drugs / Food and Drug Administration / Division of Dockets Management / DOSAGE AND ADMINISTRATION / office of Communications / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / Drug Information Center for Drug Evaluation / /

Person

Ann Marie Trentacosti / /

/

Position

Governor / /

Product

Indication / approval / Indication Under / C. / accelerated approval of an indication / use / Serious Conditions / /

ProvinceOrState

Maryland / /

URL

http /

SocialTag