Drugs

Make plans to keep your medicines safe

Aug 28 - Be prepared for fire, flood, natural disasters, and power loss

Learn More

Rare, severe lung issue with certain breast cancer drugs

Sep 13 - Watch for breathing symptoms with Ibrance, Kisqali and Verzenio

FDA investigating impurities found in some ranitidine drugs

Sep 13 - Patients wishing to discontinue use may consider other treatments

Stay updated on how to submit adverse event reports to FDA

Learn how to align submissions to new standards and requirements

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Consumers and Patients

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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

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Director's Corner

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

Sep 13

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

Sep 13

FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer

Aug 28

FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)

Drug Safety Announcements

Center

Sep 16

Fitoterapia USA Inc. Issues Voluntary Nationwide Recall of MERO MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT Due to Presence of Active Ingredient Tadalafil

Sep 12

Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error

Sep 12

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility

Center

Sep 17

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

Sep 13

Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

More Press Announcements

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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

Make plans to keep your medicines safe

Rare, severe lung issue with certain breast cancer drugs

FDA investigating impurities found in some ranitidine drugs

Stay updated on how to submit adverse event reports to FDA

Navigate the Drugs Section

Drug Information, Safety, and Availability

Drug Approvals and Databases

Drug Development and Review Process

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Regulatory Science Research and Education

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About the Center for Drug Evaluation and Research (CDER)

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Consumers and Patients

Health Care Professionals

Industry

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Opioids

Generics

Warning Letters

Guidances

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21st Century Cures at CDER

Expanded Access (Compassionate Use)

Director's Corner

Drug Safety Announcements

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer

FDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)

Drug-related Recall Announcements

Fitoterapia USA Inc. Issues Voluntary Nationwide Recall of MERO MACHO ARTIFICIAL PASSION FRUIT FLAVORED VITAMIN C LIQUID SUPPLEMENT Due to Presence of Active Ingredient Tadalafil

Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility

Drug-related Press Announcements

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

Statement alerting patients and health care professionals of NDMA found in samples of ranitidine