New drug application NDA See drug approval

PROCESS.

newborn screening The testing of human infants less than one month old to determine the presence of a particular disease (i.e., HIV/AIDS), or of certain risk factors known to be associated with that disease. Today, AIDS testing and screening of large groups of people remain controversial issues; whether or not HIV testing provides a net benefit both to the public health and to persons infected with HIV is still debated. one heavily debated issue concerns screening programs for all pregnant women and newborns. Advocates argue that such a program would be reasonable, given the accuracy of new confirmatory tests and the fact that perina-tally acquired HIV infection is less common than congenital syphilis or phenylketonuria (both are tested for routinely). Infected women, it is further argued, could make more informed choices about family planning, and infected newborns could be treated earlier.

opponents argue that testing newborns for the presence of HIV antibodies is medically ineffective and inconclusive. They argue that with an increase in screening, discrimination arises once a person (or an infant) is known to be infected. They characterize newborn screening as counter-productive and coercive, as it does not confront the difficult reality of treating newborns with HIV/AIDS. They argue that only when those with HIV infection are assured of receiving all the medical care they need, can we pursue the basic elements of infection control more resolutely and thus spare others the tragedy of this disease. See transmission.

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