четверг, 23 февраля 2012 г.

Human drugs.

12964W

Triad, Fredericksburg, TX, March 30 (Dallas). The warning letter was issued in reference to Triad's marketing of various products as part of "protocols" for disease treatment and prevention. The agency objected to labeling for products on the company's Internet web site, which contained claims that the products were intended for the cure, mitigation, treatment and prevention of disease. Specifically the company was offering what it called "protocol packages," which included "homeostasis protocols" claiming cures and treatments for specific diseases, including multiple sclerosis, lupus, inflammatory diseases, gout and fibromyalgia. Another protocol package was promoted for lupus, and one was claiming that 'near miraculous' recoveries had been reported for obesity, diabetes, arthritis, osteoporosis, chronic pain syndromes, neuropathies, chronic renal/kidney problems, all cardiovascular diseases, Alzheimer's, multiple sclerosis, Parkinson's, amyotrophic lateral sclerosis (Lou Gehrig's), stroke, paralytic paraplegics, fibromyalgia, wound healing, nephropathy, retinopathy, atherosclerosis, high blood pressure and depression. NDA, Web

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