This cohort study assesses the association between changes in Centers for Medicare & Medicaid Services reimbursement policy and erythrocyte-stimulating agent drug labels with outcomes for patients undergoing hemodialysis.
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 study describes the characteristics of completed phase 3 or 4 clinical trials in rare diseases registered at clinicaltrials.gov and assesses whether their results are publicly available.
This Viewpoint discusses the implications of recent circuit court decisions regarding commercial speech and off-label marketing of prescription drugs.
This Viewpoint details how standardized and clearly worded pharmacy leaflets provided with prescription medications could communicate succinct information about the benefits and risks of medications and improve patient expectations, knowledge, and safety.
This study found that between 1991 and 2014, there was an upward trend in Medicaid payments for insulin products regardless of formulation, duration of action, and whether the product was patented, which suggests a lack of price competition for this class of medications.
This Viewpoint emphasizes the need for final FDA regulations for e-cigarettes to address product design, flavors, and marketing that appeal to younger individuals.
Using private insurance data from 2004 to 2010, this study investigates the effect of the chlorofluorocarbon ban on out-of-pocket costs and utilization of albuterol inhalers among individuals with asthma. See the Editor’s Note by Ross and the Perspective by Redberg.
This systematic review assessed the safety and procedural success of the Lariat device, and the investigators found significant risks of major adverse events with off-label use for left atrial appendage exclusion.
This study found that few drug labels contained or referenced convincing evidence of clinical utility of biomarker testing, whereas many made recommendations based on biomarker test results. See also the Invited Commentary by Burke.
This Viewpoint describes the Food and Drug Administration’s unique device identification system for medical devices and recommends that federal agencies, specialty societies, and health care organizations collaborate to ensure that the system’s potential is fulfilled.
This study reports a lack of publicly available scientific evidence of substantial equivalence for medical devices and their predicates cleared by the FDA through the 501(k) process between 2008 and 2012.
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.