Word: fda
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Dates: during 2000-2009
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...different. These new treatments are scaled-down versions of the light-based devices used by dermatologists to treat skin ailments, all designed so that a consumer can use them. Even hair removal via an at-home laser is on the table. Leading the way: Zeno and ThermaClear, two FDA-approved antiacne devices already on store shelves. Most other products are still in development. "This trend is going to change the way consumers get cosmetic treatments," says Rick Krupnick, CEO of Light BioScience, the maker of GentleWaves, a technology that uses light-emitting diodes to combat wrinkles and revitalize the skin...
...next few weeks, Roche Diagnostics, a division of the Swiss drug giant Roche, will be ready to ship the first FDA-approved DNA diagnostic chips to labs in the U.S. The tiny gene detector, named AmpliChip, can help physicians assess how sensitive patients are to many commonly prescribed drugs. But will doctors order the test, which could cost $520? "We need to drive awareness," admits Heino von Prondzynski, global head of Roche Diagnostics. "Physicians usually don't know what to do with this information." Roche will also have to persuade insurers to cover the expense. It does have the stats...
...lifesaving alternative for gender-variant kids, but the remedy is also generating medical and ethical questions about interfering with the natural development process. The treatment--a series of injections to interrupt the brain cascade that launches puberty by regulating gonadotropin-releasing hormone (GnRH)--has not yet been submitted for FDA approval for gender-variant children. But it is available from international physicians and some U.S. doctors prescribing off-label. In February the first U.S. clinic for gender-variant children opened at Children's Hospital Boston. Throughout the process of delaying puberty with hormone blockers, the clinic offers regular checkups with...
There isn't enough evidence yet to determine the long-term effects of artificially delayed puberty, but the FDA has noted no serious side effects in the nearly 20 years hormone blockers have been used in the U.S. to treat early-onset puberty in the short term. Although some U.S. studies show that interrupting puberty can weaken bone density, preliminary findings by the medical center of the Free University in Amsterdam, which has prescribed hormone blockers for about 80 children since 1987, don't suggest any such problems. The blocker treatment is also easily reversible: puberty begins as soon...
...remains unclear whether the cancer was caused by a microchip or as the result of an injection, or who the maker of the chip was. The dog's tumor was removed in 2004, and a later examination found no recurrence. It seems that no one notified the FDA about Leon, but his case doesn't appear to worry the agency, as evident from a statement it issued when the AP brought Leon's story to light in September. "At this time, we continue to believe that the VeriChip is safe for humans," the FDA said. "In all the safety data...