Explore the latest in regulatory agencies, including legislation and policies affecting device and medication approval and safety internationally.
This analysis of dietary supplements purchased in 2014 and purchased again in 2017 examines whether stimulants that were initially present were still present after issuance of public notices by the US Food and Drug Administration to remove potentially hazardous ingredients.
This diagnostic study uses computer-simulated imaging to evaluate digital breast tomosynthesis vs digital mammography for the detection of lesions.
This Viewpoint discusses ways in which health apps can be improved and regulated by the US Food and Drug Administration to improve health in patients and confidence in the apps by physicians.
This Viewpoint discusses the US Food and Drug Administration’s approval of Epidiolex, the first cannabis-derived treatment, for 2 epilepsy syndromes and discusses wider implications.
This study characterizes the duration of clinical trials submitted to the US Food and Drug Administration for pediatric drug approvals, with a focus on drugs used for long-term therapy.
This quality improvement study examines trends across adulterated dietary supplements, containing unapproved ingredients, associated with US Food and Drug Administration (FDA) warnings.
This Viewpoint reviews provisions of the US Right to Try Act, which allows patients with life-threatening conditions access to investigational drugs without FDA approval, and calls for clarifications around patient and drug eligibility, reporting requirements, and differences from the FDA’s Expanded Access program to minimize potential harms from the law.
This Viewpoint examines the US Food and Drug Administration’s ability to make the reasons for its regulatory decisions to approve, and in some cases to reject, drugs clear to the public.
This Viewpoint describes the FDA’s guidance on digital tools that seeks to balance technological innovation with assurances that medical mobile apps and other devices that fall within the agency’s regulatory purview are safe and effective.
This study used the Drugs@FDA database to review FDA-approved “breakthrough” therapies from 2012 to 2017 (characterizing the pivotal clinical trials that serve as the basis of FDA approval), and premarket development and review times to assess the strength of evidence supporting breakthrough approvals.
This study describes expanded access and compassionate use programs created through 2017 for experimental drugs and biologics, and the timing and duration of existence of those programs relative to the date of US Food and Drug Administration (FDA) final approval.
This Viewpoint discusses concerns about the approval of nusinersen sodium by the US Food and Drug Administration for the treatment of spinal muscular atrophy.
This Viewpoint describes reforms to the ways the National Health Service (NHS) appraises cost-effectiveness and coverage of cancer drugs in England and Wales, the role of the National Institute for Health and Care Excellence (NICE) in the process, and changes in drug approval rates and access to new drugs as a result.
This Viewpoint provides historical context for advice given by the US Department of Health and Human Services in 2017 to the CDC to avoid particular words in 2019 budget requests and argues that scientific innovation can flourish only when it is protected from political interference.
This essay describes a patient’s account of experimental clinical trials for spinal muscular atrophy.
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