The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.

UPDATED 05/14/2012. New recommendations for monitoring patients, and new contraindications, and dosing & administration information for use in certain patients.

An overdose of Hydromorphone may result in life-threatening consequences, including respiratory depression (slowed breathing or suspension of breathing), low blood pressure, and reduced heart rate including circulatory collapse.

The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

Today, the U.S. Food and Drug Administration announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.

UPDATED 05/07/2012. Increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma in patients being treated with Revlimid.

[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.

The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.

On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery. The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions (surgical cuts into body tissue) in the abdomen.

The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.

The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.

The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.

The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

The U.S. Food and Drug Administration today approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues.

The U.S. Food and Drug Administration today approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex (TSC).

UPDATED 04/26/2012. Label revised to state that co-administration of Victrelis with certain ritonavir-boosted human immunodeficiency virus protease inhibitors is not recommended. Originally posted 02/09/2012

This week, the U.S. Department of Agriculture (USDA) confirmed that a dairy cow in California tested positive for atypical bovine spongiform encephalopathy (BSE, or "mad cow" disease). The USDA also confirmed the cow did not enter the animal feed or human food supply. The U.S. Food and Drug Administration is working with federal and state authorities to further investigate this case.

Undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.

Customers should immediately discontinue use of any affected product.

The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report” [INSERT HYPERLINK], detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.