Word: fda
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Dates: during 1960-1969
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After the narrow escape from the thalidomide disaster last summer, the U.S. Food and Drug Administration has been understandably cautious about approving any new drug. But last week U.S. doctors were putting unprecedented pressure on FDA to approve Flagyl, a new drug that is the most potent remedy to date for a common female complaint...
...investigational use only" to 750 doctors, who have treated almost 50,000 patients. U.S. investigators are as enthusiastic about Flagyl as their colleagues in France, Britain and Canada. Last week the A.M.A.'s Council on Drugs, which has never endorsed a drug not yet licensed by FDA, reported favorably on Flagyl, suggesting simply that "it should not be administered to women during the first three months of pregnancy...
Just as physicians were building a fire under FDA to speed approval of one new drug (see above], a doctor on the agency's own staff raked it over the coals for having approved too many drugs too fast. Pediatrician John O. Nestor, 50, joined FDA's New Drug Division two years ago because he thought it was underestimating the hazards to infants and children of drugs that might be safe enough for adults. Dr. Nestor was so disillusioned by what he saw of FDA's operations that last week he appeared before Senator Hubert Humphrey...
...Whether it can qualify for sale under an FDA license...
Yugoslav-born Dr. Stevan Durovic, developer of the drug, and the laboratories which distribute it claim that it is not sold, but that doctors using it make a $9.50 "contribution" to the Krebiozen Research Foundation. The FDA charges flatly that "Krebiozen has been promoted and sold as a cancer remedy." If this is so, FDA now has power to stop its distribution. The Government can ban further use of Krebiozen unless its promoters can show, by June 7, that they are making a truly scientific investigation of it, or that it has shown enough evidence of curative powers to justify...