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 Viewpoint discusses the potential to expand the application of “real-world evidence” from pragmatically designed studies in US Food and Drug Administration regulatory efforts.
This Viewpoint uses the example of power morcellator devices to discuss the wider scope of US Food and Drug Administration regulations and postmarketing surveillance necessary to ensure patient safety.
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 from former US FDA Commissioner Robert Califf discusses existing agency decision support tools for assessing the benefits and risks of medical products under review and the advantages of harmonizing the currently separate frameworks used for evaluating devices and for drugs and biologics.
In this Viewpoint, US Food and Drug Administration (FDA) Commissioner Robert Califf and Centers for Medicare & Medicaid Services (CMS) Administrator Andrew Slavitt discuss their agencies’ collaborations to develop standards and systems to increase the likelihood that medical products approved by the FDA are approved for coverage and payment by CMS.
This Viewpoint reviews changes made in 2016 by the US Food and Drug Administration to the content and design of US food nutrition labels.
This Medical News article discusses how the FDA’s new authority over e-cigarettes could affect adult smoking cessation.
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