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Drugs

The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States

Drugs

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USP Monograph can delay innovation of biologics

Jun 12 - Steven Kozlowski, M.D. on the need for flexible production processes

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Navigate the Drugs Section

Priority Areas & Initiatives

Opioids

Reducing the impact of opioid misuse and abuse

Generics

Ensuring access to safe, affordable, and effective generic drugs

Warning Letters

Warning and Notice of Violation Letters to Pharmaceutical Companies

Guidances

FDA's current thinking on drug development and review activities

Director's Corner

CDER Center Director Dr. Janet Woodcock speaking on drug-related topics

Office of Communications
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Silver Spring, MD 20993

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CDER Division of Drug Information