Drugs

Clinical trial diversity supports new drug approvals

Snapshots include demographic breakdown and subgroup differences

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FDA requests withdrawal of weight-loss drug Belviq, Belviq XR

Feb 13 - Increased occurrence of cancer seen in large clinical trial

FDA approves full Rx-to-OTC switch for three drugs

Feb 14 - Drugs for itchy eyes, arthritis pain now nonprescription

FDA launches modernized database of approved biological products

Feb 24 - Enhanced Purple Book has advanced search functionality

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, 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

Drug Shortages

Search the database, learn about root causes and potential solutions

Feb 18

FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems

Feb 04

FDA Updates and Press Announcements on NDMA in Metformin

Feb 03

FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)

Drug Safety Announcements

Center

Feb 24

Med Man Expands Voluntary Nationwide Recall of Up2 and Bow & Arrow Due to Presence of Undeclared Sildenafil

Feb 20

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing

Jan 31

Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

Center

Feb 24

FDA approves first generic of ProAir HFA

Feb 20

FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

More Press Announcements

CENTER FOR DRUG EVALUATION AND RESEARCH

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

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