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Food and Drug Administration

Silver Spring, Maryland

Food and Drug Administration

Silver Spring, Maryland

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Faegre Drinker Biddle & Reath LLP

Washington, D.C.

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Stanford, California

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Stanford, California

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Stanford, California

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Rutgers University

New Brunswick, New Jersey

Public Health Law Center

Saint Paul, Minnesota

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Iowa City, Iowa

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Long Beach, California

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Reno, Nevada

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Seattle, Washington

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Wilmington, North Carolina

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Fayetteville, North Carolina

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U.S Food and Drug Administration, Center for Devices and Radiological Health

Silver Spring, Maryland

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U.S Food and Drug Administration, Center for Devices and Radiological Health

Silver Spring, Maryland

Public Health Law Center

Saint Paul, Minnesota

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MemorialCare Health System

Long Beach, California

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Science Policy Analyst
Food and Drug Administration
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About Food and Drug Administration
The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices are safe, and effective. 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 assessment, and surveillance of the quality of marketed pharmaceutical products. The Office o...f Policy for Pharmaceutical Quality (OPPQ) is responsible for developing and clearly communicating science and risk-based policies and standards related to drug product quality, including application review and inspection. OPPQ will examine current policies, establish new policies, and identify research needs to ensure that drug quality policies support the availability of quality medicines for all Americans.
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