Word: fda
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Dates: during 2000-2009
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...they can eventually grow into a functioning organ--at which point the scaffold dissolves away. Langer foresees the day when scientists will be able to grow a new liver or pancreas for patients waiting for scarce donor organs. Skin grown using Langer's principles has been approved by the FDA, and cartilage for rib cages is in clinical trials...
Roche volunteered for a trial in which she took hexamethonium, a compound not currently approved by the FDA for use in humans. In these cases, the FDA requires that researchers obtain the agency's approval before administering such compounds. But because of the huge number of academic trials and the accompanying paperwork, the FDA had got into the habit of quietly discouraging universities from applying for approval, assuming that safety issues could be dealt with by the universities. Then, in 1999, the feds abruptly cracked down, stopping human research at Duke University Medical Center. One infraction they cited: the improper...
...1950s for treating high blood pressure, and was pulled only when other drugs proved more effective. "The decision to go ahead was based on the fact that this was not a new investigational drug," says Dr. Edward Miller, dean and CEO of Johns Hopkins Medicine. "On similar compounds, the FDA had ruled that their approval was not needed." Doctors, heal thyselves...
...patient has been identified only as a man in his 50s, a man who met all the FDA's qualifications for the procedure: He was at least 18 years old and of large enough build for his chest to accommodate the grapefruit-size titanium-and-plastic device. Both his original heart's pumping chambers had failed, as had all standard heart therapies. He had been rejected for a heart transplant because he also had diabetes, kidney failure and he was drowning internally from pulmonary edema, a buildup of fluid in the lungs that occurs in heart failure...
...suit when he was a Senator and shows little zeal for prosecuting the industry further. Another round of federal excise taxes, championed by Clinton, is not in the offing. To pre-empt harsher regulations and win protection against future lawsuits, Philip Morris is even asking Congress to grant the FDA limited oversight. Such longtime foes as Illinois Senator Dick Durbin are nonplussed. "It's laughable," he says, referring to the DOJ's settlement talks. "In a real negotiation, they could have included [FDA] regulation with teeth. Now they'll be lucky to get anything...