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The U.S. Food and Drug Administration (FDA) has been busy distributing warning letters to those in violation of the Current Good Manufacturing Practice (CGMP) rules. The recent recipients of these particular warning letters include dietary supplement distributer Gaspari Nutrition Inc. and supplement manufacturer Rasi Laboratories. In a letter dated March 2, 2011, the FDA…

In an attempt to avoid, what could be, overwhelming ramifications for medical device manufacturers, industry leaders in transvaginal mesh production have acknowledged the need for increased safety studies and label changes for their products. This acknowledgement comes in response to a meeting that is currently being held to decide the fate of transvaginal mesh…

Kaletra (generic: lopinavir/ritonavir) is an oral solution that is used in the treatment of the infection caused by the human immunodeficiency virus (HIV). Kaletra is designed to inhibit the progression of symptoms in patients infected with HIV. However, the Food and Drug Administration (FDA) recently notified healthcare professionals of the severe, life-threatening complications associated…

Chron’s disease is an inflammatory bowel disease (IBD) characterized by inflammation and ulcers that affect the lining of the digestive tract. The disease can often be debilitating and may also lead to serious, life-threatening complications. In this article we will discuss the signs and symptoms, causes, risk factors, complications, tests and diagnosis, and treatments…

A ventricular septal defect (VSD) is a congenital birth defect that affects the hearts septum, the wall that separates the left and right sides of the heart. This defect is characterized by a hole in the heart that is unable to properly separate the right and left ventricle. The result is an excess of…

Yasmin Lawsuit Update:Officials at the U.S. Food and Drug Administration (FDA) held a meeting on December 8 to discuss the safety and effectiveness of Bayer’s popular Yasmin. According to meeting notes, a panel of outside experts voted that the current labeling of Yasmin does not adequately reflect the risks associated with the contraceptive. Subsequently,…

Today, the FDA is meeting with its obstetric and gynecologic medical devices “advisory committee” to “help” the Agency decide the fate of surgical mesh devices commonly used in pelvic surgery on women, including procedures to remedy vaginal prolapse and urinary incontinence. The committee is supposed to be a group of outside “experts,” including a…

The popular osteoporosis medication Fosamax (alendronate sodium) has been linked to osteonecrosis of the Jaw (ONJ), femur fractures, and severe musculoskeletal pain. If you or a loved one has been injured by Fosamax, you should contact our lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries…