Median approval times for class III medical devices have been well above statutory deadlines set for FDA and CMS.

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) play key roles in making safe and effective medical devices available to the public. Since 1997 Congress has passed "modernization" laws that specify statutory deadlines for these agencies to review manufacturers' applications for premarket approval--the process by which the FDA evaluates the safety and effectiveness of class III medical devices, those that pose the highest risk--and applications for national coverage by Medicare. We questioned whether these reforms shortened approval time at the FDA and CMS.

Demographic and spatial analysis of West Nile virus and St. Louis encephalitis in Houston, Texas.

This descriptive prevalence study describes the relationships between mosquito density and the presence of arboviruses (in mosquitoes and humans) with various socioeconomic and environmental factors present near the time of teh arbovirus outbreak in Harris County, Texas, in 2002. This study suggests that mosquito density increased if the trap was located in an area with a large number of containers that may inadvertently retain rainwater (P = 0.056).

Biologic and social determinants of sequelae and long-term survival of pediatric HIV in Romania.

Purpose: The aim of the study is to investigate the effect of social context and clinical factors on survival in a cohort of 333 children to identify issues useful in the treatment and care of human immunodeficiency virus (HIV)-infected youth in developing countries.

Methods: A prospective cohort study design was used, and data were gathered at baseline and 1-year follow-up. The study cohort consisted of children given a diagnosis of HIV between 1995 and 1999 and receiving medical care in Constanta, Romania.

Alternatives to HIV-RNA and CD4 count to monitor HIV disease progression: a prospective cohort study in Romania.

Little evidence exists on how to efficiently and effectively monitor HIV-disease progression in developing countries. Better understanding regarding cost-effective tests may help to resolve questions regarding treatment. A prospective cohort study was conducted with a 1-year follow-up period.