A newly proposed US Food and Drug Administration guidance could undermine the agency's drug safety laws and regulations by allowing pharmaceutical companies to claim their drugs are less risky than stated in the approved label.
This study assesses factors associated with regulatory approval or reasons for failure of investigational therapeutics in phase 3 or pivotal trials and rates of publication of trial results.
This nested case-control study evaluates the association of unconventional natural gas development processes with asthma exacerbations.
Smith et al compare the relative clinical cardiovascular safety of 2 commonly used oral estrogen drugs—conjugated equine estrogens and estradiol. Their case-control study compares cardiovascular event risk among 384 postmenopausal women aged 30 to 79 years using oral hormone therapy. Incident venous thrombosis was the primary clinical outcome.
This review describes research from the past 5 years demonstrating significant advances in understanding the actions of endocrine-disrupting chemicals on endocrine health and disease.
This study uses data from 2 survey studies to examine associations between change in home-to-tobacco-outlet distance and change in smoking status among community-dwelling Finns.
This historical analysis uses internal sugar industry documents to describe how the industry sought to influence the scientific debate over the dietary causes of coronary heart disease in the 1950s and 1960s.
This longitudinal cohort study analyzes the association of red blood cell donor age and sex with the survival of transfusion recipients.