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Similar trials of recombinant DNA-produced human growth hormones received FDA approval and began in February at Stanford Medical School. This protein, with its potential for curing dwarfism and possibly fractured bones, will first be tested for safety in 20-day trials on adult volunteers and then in a one-year study of effectiveness that will follow...
Erbe attributed this increase to several factors. For example, the trend of women delaying having children until after they have established a career has led to an increased probability of birth defects. But a Food and Drug Administration (FDA) review of the manufacture of the immunological reagents required by the procedure has delayed its use on a large-scale basis. The agency is expected to set down regulations on the use of these chemicals this summer...
Because the laboratories cooperating with the Erbe and Holmes effort antedate the regulation, they can continue AFP testing without waiting for FDA approval. These research centers include the Eunice Kennedy Shriver Center in Waltham, where Dr. Aubrey Millunsky, assistant professor of Pediatrics, has been directing AFP testing since 1973, and the Foundation for Blood Research in Scar-borough, Maine...
...Drug Administration has designated the cap an "investigational device." Beginning this week, caps will be available only to women enrolled in research studies. The agency notes that no major published work on the caps' safety and effectiveness has appeared since 1953. Says Dr. Lillian Yin of the FDA: "We just don't know if there will be a problem with abrasion of the cervix, and we don't know what will be the rate of infection or the long-term problem with tissue erosion." But critics charge that the FDA is being overcautious. Dr. D.J. Patanelli...
Though suggestive, the findings do not firmly establish a relationship between caffeine and human birth defects. After all, people are not force-fed caffeine by tube into the stomach, and they may not metabolize the chemical in the same way as rats. The FDA will attempt to resolve these issues by further studies. Meanwhile, the National Coffee Association and the soft-drink industry have announced plans to do their own surveys of pregnant women to determine patterns of caffeine consumption and birth defects...