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Science Policy Analyst in Silver Spring, MD for Food and Drug Administration
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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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