Explore the latest in regulatory agencies from The JAMA Network, including legislation and policies affecting device and medication approval and safety internationally.
This Viewpoint discusses a new FDA regulatory plan to reduce the burden of smoking-related disease by requiring reduction of nicotine in combustible tobacco products beneath addicting levels and by encouraging innovations in novel reduced-risk nicotine products.
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 cross-sectional analysis quantifies research payments made by the health care industry to otolaryngologists and compares the field of otolaryngology with other surgical specialties.
This Viewpoint discusses the Laser-Assisted In Situ Keratomileusis (LASIK) Quality of Life Collaboration Project, which developed a questionnaire to capture the patient’s experience following LASIK surgery with the ultimate goal of quantifying these patient-reported outcomes in the LASIK population.
This Viewpoint discussed drug companies’ disputed First Amendment rights and the US Food and Drug Administration’s enforcement authority.
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 study analyzes the US Sunshine Act Open Payment database for information about the nature and extent of industry payments to dermatologists.
This cohort study assesses the association between changes in Centers for Medicare & Medicaid Services reimbursement policy and erythrocyte-stimulating agent drug labels with outcomes for patients undergoing hemodialysis.
This randomized clinical trial examines the effects of incentives and restrictions on types of food purchases on nutrition in a food benefit program.
This Viewpoint discusses the need to balance speed of approval and safety of drugs in the US Food and Drug Administration’s process of drug approval.
This Viewpoint discusses creation of a US evaluation system for health technology that could quickly identify problematic devices, accurately and transparently characterize and disseminate information about device performance in clinical practice, and efficiently generate data to support premarket clearance or approval of new devices and new uses of currently marketed devices.
This case report describes an incident of increased airport scrutiny by the Transportation Security Administration of a patient-passenger carrying ammonium lactate–containing moisturizer.
This Teachable Moment discusses the how the Centers for Disease Control and Prevention guidelines for opioid prescribing can play a major role in limiting the impact of this epidemic.