Sacks and coauthors identify the reasons that US Food and Drug Administration (FDA) marketing approval for new drugs was delayed or denied in drug applications for new molecular entities first submitted to the FDA between 2000 and 2012.
Using the US FDA’s premarket approval (PMA) database, Rome and coauthors analyzed the prevalence and characteristics of changes to cardiac implantable electronic devices made through the PMA supplement process. In an Editorial, Goodman and Redberg discuss how FDA policies of transparency can help balance innovation and protection of public health.
Schultz and coauthors report preliminary data on microRNA biomarkers in whole blood for detection of pancreatic cancer. In an accompanying Editorial, Buchsbaum and Croce discuss whether detection of microRNA biomarkers in blood improve the diagnosis and survival of patients with pancreatic cancer.
Sun and coauthors provide 5 criteria to help clinicians distinguish credible subgroup analyses from spurious subgroup analyses.
This study examined the role of a Mediterranean diet in the prevention of peripheral artery disease (PAD) in a derivative analysis of the PREDIMED randomized clinical trial in adults older than 55 years with diabetes or cardiovascular risk factors.
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