Drugs

CDER is engaged in essential COVID-19 activities to protect and promote public health

Ranging from the acceleration of development for treatments for COVID-19, maintaining and securing drug supply chains, providing guidance to manufacturers, advising developers on how to handle clinical trial issues, and keeping the public informed

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Xofluza indication expanded for post-exposure flu prevention

Nov 23 – For patients 12-and-older after contact with someone with the flu

First drug approved to treat rare metabolic disorder

Nov 23 – For disorder that causes recurrent kidney stones and kidney function loss

Emergency use authorization issued for COVID-19 treatment

Nov 21 – Combination of two human monoclonal antibodies for treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years or older with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19

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, international information, 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

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