This study characterizes the quality of clinical studies and data used to support US Food and Drug Administration approval of modifications to high-risk medical devices.
This study uses public US Food and Drug Administration (FDA) data to characterize drug trials used to obtain FDA accelerated approval and to describe the existence, timing, and characteristics of postapproval trials mandated by the FDA as part of the accelerated approval decision.
This randomized clinical trial compared the effects of an intensive lifestyle intervention vs standard care on glycemic control and medication reduction among participants with non–insulin-dependent type 2 diabetes.
This study assesses public response to a proposed field trial in the United States of genetically engineered mosquito (OX513A) designed to suppress wild-type Aedes aegypti mosquitoes, which can transmit diseases such as Zika, dengue, and chikungunya.
This Viewpoint argues that Medicare coverage should be expanded to include dental, vision, and hearing services, and discusses ways to structure the benefit.
This Viewpoint discusses the potential benefits and harms of diagnostic stewardship—modifying the ordering, performance, and reporting of diagnostic tests to improve treatment—as a means of reducing inappropriate antibiotic use.
This Viewpoint discusses a New York law that allows the state to negotiate rebates with manufacturers to obtain value-based prices for drugs in its Medicaid program and assesses the potential effects of value-based pricing.
This review discusses the the role of a gluten-free diet in the clinical management of celiac disease and nonceliac gluten sensitivity and highlights the importance for long-term therapy of distinguishing between these conditions.
This Clinical Evidence Synopsis summarizes a Cochrane review of clinical trials evaluating patient decision aids designed to help patients understand their treatment options.
This Medical Letter review summarizes the indications, risks, and benefits of bezlotoxumab, a monoclonal antibody to be used with antibacterial drug treatment to reduce recurrence of Clostridium difficile infection in adults at high risk.
This Medical News story discusses the founding of the first free clinics in the United States and the role free clinics continue to play in communities across the country.