Drugs

Man looking at bottle of medicine talking with pharmacist

How to talk to your pharmacist about your medicines

Oct 15 - Tell them about health issues and ask them these questions

Learn More

Register to learn what's new in pharmaceutical quality

Oct 16-17 - Get information on assuring the safety and efficacy of drugs

2019 Electronic Drug Registration and Listing Under CDER Direct

Attend a workshop on electronic drug registration and listing

Oct 22 - Get help with creating complete and accurate online submissions

FDA approves drug for short-term treatment of migraine

Oct 11 - For adult patients with a history of migraine with or without aura

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 & Regulatory Information

Guidances, warning letters, drug compounding, 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

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

Health Care Professionals

Get drug safety, recall, and shortage information. Report drug adverse events. Find jobs at FDA. Watch training/education videos and courses.

Industry

Search drug databases. Find guidance, submission, user fee, and meeting information. Get small business assistance. Find jobs at FDA.

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 Development Tools Qualification Program

Using scientific and technical innovations for better drug development

21st Century Cures at CDER

Bringing innovative and advanced medicines to patients faster

Expanded Access (Compassionate Use)

Providing access to investigational drugs outside of clinical trials

Director's Corner

CDER Center Director Dr. Janet Woodcock speaking on drug-related topics

Oct 18

FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo)

Oct 17

FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease

Oct 15

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

Drug Safety Announcements

Center

Oct 15

Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables Due to a Lack of Sterility Assurance

Oct 10

Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance

Sep 25

Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) due to the potential for Detection of an Amount of Unexpected Impurity,N-nitrosodimethylamine (NDMA) Impurity in the product

Center

Oct 16

Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs

Oct 11

FDA approves new treatment for patients with migraine

More Press Announcements

Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993

druginfo@fda.hhs.gov

Toll Free

(855) 543-3784

(301) 796-3400

Hours Available

CDER Division of Drug Information

U.S. Food and Drug Administration