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Pharmaceutical sciences / Biosimilar / Center for Biologics Evaluation and Research / Biologic / New Drug Application / Center for Drug Evaluation and Research / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Health


Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 Guidance for Industry
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Facility

Hillandale Bldg. / /

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IndustryTerm

auto-injector device / subsequent biological product / chemical synthesis / biological products / biological reference product / container closure systems / patent disputes involving applications / reference product / proposed interchangeable product / biosimilar product / delivery device / interchangeable products / combination product / biological product / proposed biosimilar products / biosimilar products / healthcare / injectable reference product / certain biological products / healthcare providers / drug products / proposed biosimilar product / /

Movie

A. I.2 / A. I.3 / A. I.5 / A. I.4 / A. I.6 / A. I. / /

Organization

U.S. Department of Health and Human Services / Food and Drug Administration Center for Drug Evaluation and Research / Food and Drug Administration / office of Communications / U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research / CDER’s office of New Drugs / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / Drug Information Center for Drug Evaluation / CDER’s office of Medical Policy / /

Person

Floor Silver Spring / Sandra Benton / /

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Position

gov. For general questions related / /

Technology

pdf / /

URL

http /

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