Word: fda
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Minnesota ALG, as it became known, turned out to be highly effective. As patient survival rates improved, other surgeons clamored to get hold of the potion. Between 1970, when Najarian obtained permis-sion from the FDA to produce and use the compound on an experimental basis, and 1992, when the FDA shut down the operation, Minnesota ALG was shipped to 175 transplant centers around the world and was used by more than 50,000 patients. Along the way, it generated an estimated $80 million in revenues, enough to finance a $13 million production facility on the University of Minnesota...
...Food and Drug Administration is going to let private firms decide whether certain medical devices are safe and effective enough for patients. The White House today announced a package of FDA reforms geared to save the industry $500 million a year. They are expected to start in early 1996 with a two-year pilot program permitting private companies to review low-risk devices such as cholesterol tests. The manufacturers would pay for the reviews and the agency could overrule them.TIME Washington correspondent Dick Thompsonsays the FDA cautiously selected devices to be tested privately, based on similar testing systems already...
...lawsuits to settle or else risk paying a portion of the other side's legal fees. Another would establish national standards for product-liability cases and cap punitive damages in civil cases. After lobbying by pharmaceutical companies and doctors, the latter bill was amended to immunize the makers of FDA-approved drugs and devices from punitive damages and cap medical-malpractice awards for pain and suffering...
Upping the ante in the tobacco debate, FDA Commissioner David Kessler said that nicotine addiction begins when most smokers are teenagers and that smoking should properly be addressed as a "pediatric disease." The FDA, he said, is still studying whether to regulate or restrict the sale of tobacco-moves that would probably displease the current Congress...
...technical policy and public-service director Edward Groth III calls the fda letter to Hansen "hogwash, a propaganda document put out to discredit his report." Groth defends Hansen's expertise and explains CR's position on bst: "The literature shows there is possibly a problem but no conclusive proof. Scientist A says we should be cautious. Scientist B says let's go ahead. Science sometimes carries more weight than it should. Science is good, but in policy you need value judgments...