Drugs

This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses. Note the spikes that adorn the outer surface of the virus, which impart the look of a corona surrounding the virion, when viewed electron microscopically. A novel coronavirus, named Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), was identified as the cause of an outbreak of respiratory illness named coronavirus disease 2019 (COVID-19).

This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals the ultrastructural morphology exhibited by coronaviruses.

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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Drug Master File (DMF) Workshop outlines high-quality submissions

Mar 3 - Will provide guidance on the DMF submission process and expectations

FDA to share current thinking on Non-alcoholic Steatohepatitis (NASH)

Jan 29 - Webinar to focus on NASH drug development and clinical trial efforts

Webinar to provide overview of Over-the-Counter Monograph Reform

Jan 27 - Will discuss safety issues: identification, evaluation and response

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.