FDA NEWS

Chantix (varenicline)
UPDATE - Prescribing information revised to include safety information regarding serious neuropsychiatric symptoms in the WARNINGS and PRECAUTIONS sections of the label. Additionally, a Medication Guide for patients is available.

A Guide to Drug Safety Terms at FDA
This guide offers descriptions of some of the more common drug safety terms used by FDA throughout the life cycle of a drug.

FDA Embarks on Major Hiring Initiative for its Public Health Mission
The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.

New Efforts to Help Improve Medical Products for Patient Safety and Quality of Medical Care
HHS Secretary Mike Leavitt today announced efforts underway at the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) that will complement each other to improve patient safety and the quality of medical care.

FDA Approves Relistor for Opioid-Induced Constipation
The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

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