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Smithfield Foods Logo
Smithfield Foods

Denison, Iowa

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Major, Lindsey & Africa Logo
Major, Lindsey & Africa

St. Paul, Minnesota

Regeneron Pharmaceuticals

Sleepy Hollow, New York

University of Connecticut Logo
University of Connecticut

Storrs Campus

Cibus Logo
Cibus

Roseville, Minnesota

Food and Drug Administration (FDA)

Silver Spring, Maryland

Smithfield Foods Logo
Smithfield Foods

Lincoln, Nebraska

Food and Drug Administration (FDA) Logo
Food and Drug Administration (FDA)

Remote Eligible, Maryland

Smithfield Foods Logo
Smithfield Foods

Denison, Iowa

Nestlé Purina North America

Saint Louis, Missouri

University of California San Francisco Logo
University of California San Francisco

San Francisco, California

Cargill Logo
Cargill

North Kingstown, Rhode Island

University of North Carolina at Chapel Hill

Chapel Hill , North Carolina

Vanderbilt Health Logo
Vanderbilt Health

Nashville, Tennessee

Johns Hopkins University Logo
Johns Hopkins University

Baltimore, Maryland

Scout Cold Logistics Logo
Scout Cold Logistics

Coral Gables, Florida

Food and Drug Administration

Silver Spring, Maryland

Stanford University Logo
Stanford University

Stanford, California

Smithfield Foods

St. Charles, Illinois

Smithfield Foods

St. Charles, Illinois

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Regulatory Counsel
Introduction The Center for Drug Evaluation and Research (CDER) is responsible for regulating prescription drugs, including new drugs, generic drugs, biological products and biosimilars as well as over-the-counter drugs (OTC).  CDER’s drug regulatory responsibilities include premarket review of new drugs and generic drugs; maintenance of the OTC drug monograph system; monitoring of all marketed drug safety and promotion activities; review, monitoring, and enforcement of drug quality during the entire drug life cycle; and ensuring drug products in the market comply with the law. The Office of Pharmaceutical Quality (OPQ) oversees and coordinates the overall regulation of human pharmaceutical quality within CDER, including submission review, manufacturing facility assessme


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