Drugs

The Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States

Topic Paragraphs

FDA Issues Final Guidance on Prescription Drug Apps and Software

FDA is providing clear guidance on prescription drug apps and software to help reduce uncertainty for developers, support innovation, and help ensure patients receive accurate, evidence-based information.

Learn more

Consumer Contact Information Drug Alerts and Statements What's New Related to Drugs

Drugs@FDA

Find information about most FDA-approved prescription, generic, and over-the-counter drug products.

Drug Shortages

Find information about drug shortages caused by manufacturing and quality problems, delays, and discontinuations.

National Drug Code Directory Search

Find information about finished drug products, unfinished drugs, and compounded drug products.

Orange Book

The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness.

Attention: Patients Taking GLP-1 RAs

Potential Increased Risk of Rare But Serious Eye Condition

caretaker assisting elderly woman in a healthcare facility

FDA Approves First Factor Xla Inhibitor

To reduce the risk of stroke after ischemic stroke or TIA

FDA Approves Once-Weekly Generic Hormone Therapy Patch for Women

Once-Weekly Generic HT Patch

Treats vasomotor symptoms due to menopause

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

Generics

Ensuring access to safe, affordable, and effective generic drugs

Updates, News, Events, and Training

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

Center

Workshop

Dec 01

FDA/Center for Research on Complex Generics (CRCG) Workshop on Long-Acting Injectable (LAI) Generics: Advancing Innovation in Product Development and Regulatory Assessment

Public

Mar 05

FDA Rare Disease Day 2027

More Events

Biosimilars Education Initiative

Learn how biosimilars are safe and effective treatment options

Opioids

Reducing the impact of opioid misuse and abuse

Emergency Preparedness

Prepare and respond to natural disasters, nuclear and chemical attacks

Warning Letters

Warning and Notice of Violation Letters to Pharmaceutical Companies