Word: fda
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...controversy is not likely to go away. At week's end the panels adjourned without making a formal recommendation on the labeling issue to FDA Commissioner David Kessler. Most panel members felt that the disputed labels should not be required. They also believed that milk processors ought to be able to advertise their products as hormone free, although it is not clear whether the FDA will allow that. Both sides felt that they had lost something, and those who wanted the hormone banned outright vowed to take their case to shoppers across...
...available source of the hormone was the pituitary glands of butchered cows, which yield only minute quantities. Then, in 1982, scientists used new gene-splicing techniques to manipulate bacteria into mass-producing BGH. By the mid-1980s, four drug companies -- including Monsanto and Eli Lilly -- had applied to the FDA for permission to market the product...
Before giving the Reality condom final approval, the FDA asked that two caveats be put into the labeling. First, the agency wants a statement that male condoms are still the best protection against disease. Wisconsin Pharmacal thinks the polyurethane used in the female condom may be more effective against viruses than the latex of male condoms, but not enough studies have been done to know for sure...
...second FDA demand is that the label compare the effectiveness of female condoms with that of other barrier methods of birth control. According to the FDA, in a study of 150 women who used the female condom for six months, 26% became pregnant. The manufacturer contends that the pregnancy rate was 21% -- and only because many women didn't use the condom every time they had sex. With "perfect use," company officials say, the rate is 5%, in contrast to 2% for male condoms...
Resolving the dispute over what failure rate to put on the label has delayed approval. However, the FDA is eager to get the product on the market, since it could be a lifesaver for women whose partners refuse to use a condom. Says FDA Commissioner David Kessler: "The female condom is not all we would wish for, but it is better than no protection...