Drugs (original) (raw)
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
Call-To-Action Title
Regulating and Approving Drugs Video Series
FDA uses science and data to ensure that approved drugs are of a high quality, safe, and effective. Learn more about the FDA’s role in reviewing, approving, and monitoring drugs in the latest videos that are now available in Spanish.
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.
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, 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
Biosimilars Education Initiative
Learn how biosimilars are safe and effective treatment options
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 Shortages
Search the database, learn about root causes and potential solutions
Resources
Information for consumers, health professionals, and industry
Disposal of Unused Medicines
Learn how to properly get rid of unused or expired medication