Word: fda
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Dates: during 2000-2009
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...better too--and if they don't, the government must push them to do it. There is a lot of money to be made in developing the next Prozac, but there is less profit if you test it for longer than the law demands. The Food and Drug Administration (FDA) doesn't require long-term studies that follow patients over decades. Its only requirement is toxicity trials that span six to eight weeks. In an effort to entice companies to conduct lengthier studies, the agency now grants an extension of six months of exclusive marketing rights to any company engaging...
...researchers discovered that parathyroid hormone (PTH), an FDA-approved hormone for treating osteoporosis, had the same effect as the mice’s protein, increasing the number of stem cells. Mice treated with PTH who underwent bone marrow transplants had a 100 percent survival rate in the study...
...conditions on their approval. The manufacturer must continue to follow patients for 10 years, it must give women coming in for implants information about scarring, ruptures and other complications, and it must advise women who get silicone implants to have annual exams to check for slow leaks. The FDA is expected to make its final decision within weeks and typically follows the lead of its advisory panels...
...interfere with mammography—potentially delaying or hindering the early detection of breast cancer. The surgery can also dramatically reduce sensitivity in the nipple and may affect sexual response or the ability to nurse a baby. From 1985 until January 2000, 195,202 women complained to the FDA about medical problems experienced from their breast implants, and the FDA’s own epidemiologists have identified long-term potential health risks from silicone implants, such as fibromyalgia. Just this month, the 11th Circuit Court of Appeals agreed to hear a lawsuit against former manufacturers of breast implants, including Baxter...
Despite the women’s protests, last week an advisory panel to the FDA voted to recommend that silicone breast implants be allowed back on the market after a prohibition that has lasted for the past eleven years. In 1992, the United States banned breast implants filled with silicone gel after hundreds of women complained that ruptured implants had leaked silicone into their bodies and caused long-term chronic immune system disorders. Saline implants, though less “natural” in appearance and feel, were used alternatively after...