Drug approved for breast cancer with certain genetic features

May 24 - Used in combination therapy for men and postmenopausal women

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CDER launches redesigned performance tracking webpage

May 22 - Displays key performance measures throughout the drug lifecycle

Register to learn about FDA's regulatory requirements

May 29-30 - Get information from FDA experts on preparing regulatory filings

Improving consumer understanding of drug risks and benefits

Feb 05 - By identifying elements of drug ads that affect viewer attention

Drug Information, Safety, and Availability

Medication Guides, Drug Safety Communications, Shortages, Recalls

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Drugs@FDA, Orange Book, National Drug Code, Recent drug approvals

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About the Center for Drug Evaluation and Research (CDER)

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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

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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

Risks associated with the investigational use of Venclexta in Multiple Myeloma

Mar 21 - FDA issues Alert based on data from a clinical trial.

Harm reported from sudden discontinuation of opioid pain medicines

Apr 09 - FDA requires label changes to guide prescribers on gradual, individualized tapering

Updates on Angiotensin II Receptor Blocker (ARB) Recalls

Apr 29 - Latest news on ARBs - medicines used to treat high blood pressure and heart failure

Center

May 11

Novartis Issues Voluntary Nationwide Recall of Promacta® 12.5 mg for Oral Suspension Due to Potential Peanut Contamination

May 06

STIFF BOY LLC. Issues Voluntary Nationwide Recall of THE BEAST Capsules Due to Presence of Undeclared Sildenafil

May 03

D.B.P. Distribution Issues Voluntary Nationwide Recall of Titanium 4000 Due to Presence of Undeclared Sildenafil and Tadalafil

Center

May 24

FDA approves first PI3K inhibitor for breast cancer

May 23

FDA authorizes marketing of first diagnostic test for detecting Zika virus antibodies

More Press Announcements

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