Drugs

Use antibiotics properly to prevent antibiotic resistance

Learn what antibiotics are and which infections they treat

Learn More

Patient in hospital bed. Doctor taking notes.

FDA approves drug for complicated urinary tract infections

Nov 15 - Expands treatment for adult patients with kidney inflammation

2019 CDER Prescription Drug Labeling Conference, December 4-5, 2019

Learn about developments in prescription drug labeling

Dec 4-5 - FDA labeling specialists will share approaches, challenges, methods

Drug approved to prevent, reduce blockage of blood vessels

Nov 15 - For patients with sickle cell anemia aged 16 years and older

Drug Information, Safety, and Availability

Medication Guides, Drug Safety Communications, Shortages, Recalls

Drug Approvals and Databases

Drugs@FDA, Orange Book, National Drug Code, Recent drug approvals

Drug Development and Review Process

Drug applications, submissions, manufacturing, and small business help

Guidance, Compliance & Regulatory Information

Guidances, warning letters, drug compounding, registration and listing

Regulatory Science and Research

CDER research programs, initiatives, and resources

Emergency Preparedness

Prepare and respond to natural disasters, nuclear and chemical attacks

Updates, News, and Events

Recent approvals, meetings, workshops, blogs, podcasts, stay connected

About the Center for Drug Evaluation and Research (CDER)

Our role, mission, organization, history, leadership, job openings

Consumers and Patients

Find drug information. Report drug side effects. Learn how to buy, use, and dispose of unused drugs. Attend a public meeting.

Health Care Professionals

Get drug safety, recall, and shortage information. Report drug adverse events. Find jobs at FDA. Watch training/education videos and courses.

Industry

Search drug databases. Find guidance, submission, user fee, and meeting information. Get small business assistance. Find jobs at FDA.

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

Drug Development Tools Qualification Program

Using scientific and technical innovations for better drug development

21st Century Cures at CDER

Bringing innovative and advanced medicines to patients faster

Expanded Access (Compassionate Use)

Providing access to investigational drugs outside of clinical trials

Drug Shortages

Search the database, learn about root causes and potential solutions

Nov 12

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

Nov 07

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

Nov 01

Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)

Drug Safety Announcements

Center

Nov 13

Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules due to an Undeclared PDE-5 Inhibitor Found in The Product

Nov 08

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

Nov 08

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

Center

Nov 15

FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease

Nov 15

Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product

More Press Announcements

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