Word: fda
(lookup in dictionary)
(lookup stats)
Dates: during 1990-1999
Sort By: most recent first
(reverse)
...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...
...story by relying solely on its in-house critic in the field, Michael Hansen, rather than a panel review. "Nobody has the credibility to handle a wide range of issues," Bauman says. He adds that he found a Hansen report on bst "replete with mistakes" and that the fda sent Hansen a letter listing all the errors. "I don't think this helps the magazine's credibility," Bauman observes...
...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...