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

Learn More

Drug approved for seizures related to tuberous sclerosis complex

Aug 4 - Treatment for patients one year of age and older

Smiling child in wheel chair looking at pamphlet held by a woman

FDA approves drug for patients with Spinal Muscular Atrophy

Aug 7 - Treatment for patients 2 months and older

Updated Purple Book, includes CDER and CBER biological products

Aug 6 - New version features a glossary and exclusivity information

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.