This Viewpoint describes how the US Food and Drug Administration’s 2006 Unapproved Drugs Initiative may have unintentionally made generic drugs more expensive and inaccessible and proposes policy reforms to address the harms of those price increases.
This study uses the Drugs@FDA database to analyze clinical development times for drugs to treat serious diseases within the 4 FDA expedited programs intended to speed drug review and approval.
This Viewpoint discusses the potential risks of the US Food and Drug Administration’s 2016 approval of the Dexcom G5 Mobile continuous glucose monitor for making diabetes treatment decisions without confirmation of the device’s readings with fingerstick or laboratory testing.
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 Viewpoint uses the example of the US FDA’s 2017 approval of desmopressin for treatment of nocturia to discuss the risks of approving a drug for symptoms rather than disease and the ways that the drug approval process is influenced by manufacturers and by overreliance on statistical vs clinical significance.
This study describes withdrawals, boxed warnings, and safety communications affecting pharmaceuticals and biologics approved by the US Food and Drug Administration between 2001 and 2010, and associations between characteristics known at the time of approval and those events.
This Viewpoint argues that publication by the European Medicines Agency of clinical study reports as part of its approval process for commercial drugs sets a standard of transparency that could challenge the reputation of the US Food and Drug Administration as the international standard-bearer in drug and device approval.
This Viewpoint discusses potential threats to public health that arise from provisions of the 2016 21st Century Cures Act that allow drug manufacturers to use surrogate measures of safety and that encourage the US Food and Drug Administration to emphasize speed over science in the drug approval process.
This Viewpoint discusses controversies surrounding the US Food and Drug Administration’s 2016 approval of eteplirsen for treatment of Duchenne muscular dystrophy.
This survey study examines how well physicians understand the US Food and Drug Administration’s (FDA’s) statutory definition of a “breakthrough” therapy, and whether the term breakthrough affects their perceptions of a drug’s efficacy.
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.
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