Drugs

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Drug approved to treat type of metastatic stomach tumor

Jan 9 - For adult patients with the presence of a mutated gene

Possible higher cancer risk with Belviq, Belviq XR

Jan 14 - Consider benefits & risks of using this weight-loss drug

Innovative new drug therapies for the American public

Jan 6 - New treatments for rare diseases and other key advances

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, and 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

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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

Jan 08

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

Dec 19

FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)

Nov 07

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

Drug Safety Announcements

Center

Jan 15

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

Jan 10

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

Jan 08

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited

Center

Jan 09

FDA approves the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

Dec 23

FDA approves new treatment for adults with migraine

More Press Announcements

CENTER FOR DRUG EVALUATION AND RESEARCH

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druginfo@fda.hhs.gov

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CDER Division of Drug Information

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