Explore the latest in regulatory agencies, including legislation and policies affecting device and medication approval and safety internationally.
This cross-sectional study compares the distribution of National Institutes of Health (NIH) research project grants among surgeon-scientists over a 25-year period by gender.
This systematic review with meta-analysis examines the regulatory oversight of the accelerated approval pathway and evidence generation for idelalisib during premarketing, postmarketing, and premarketing withdrawal periods.
This Viewpoint discusses the benefits of expanded access research, the usefulness of expanded access data, the issues surrounding cost and transparency, and the adjusted role of institutional review boards.
This study examines the Food and Drug Administration’s accelerated approval pathway and whether preapproval initiation was associated with faster conversion to traditional approval or withdrawal for drugs with nononcology indications.
This cross-sectional study of National Institutes of Health (NIH) grants examines trends in gender, racial, and ethnic diversity among principal investigators, with a particular focus on investigators holding 3 or more research project grants.
This cohort study examines the postapproval processes and timing for making palbociclib, ribociclib, and abemaciclib available to patients with metastatic breast cancer in a high-income country.
This cross-sectional study evaluates regulatory decisions and health technology assessments in Australia, Canada, and the UK regarding new drugs approved by the US Food and Drug Administration in 2017 through 2020, as well as estimates the US cost per patient per year for drugs receiving negative recommendations.
This cross-sectional study determines the frequency of and rationale for US Food and Drug Administration (FDA) approval of drugs not meeting pivotal trial primary efficacy end points.
This cross-sectional study evaluates the association between the 2021 varenicline tartrate recall and prescribing of varenicline and other medications for nicotine dependence in a large US national patient cohort.
This study examines the use of single-arm trials for US Food and Drug Administration drug approvals.
This Viewpoint discusses recent legal directives by the DHHS and FDA that could increase health care entities’ liability for possible discriminatory biases of clinical algorithms and the need for additional legal clarity to avoid adverse effects on algorithm development and use.
This cross-sectional study investigates the use of patient-reported outcome measures in new marketing authorizations for oncology drugs approved by the European Medicines Agency (EMA) between 2017 and 2021.
This cross-sectional study explores delayed and incomplete enrollment in surgical randomized clinical trials.
This Viewpoint from leadership at the US Food and Drug Administration (FDA) proposes the creation of a comprehensive “care package” framework of resources to help maximize cessation of tobacco use, including components focused on strategies at the individual, health system, and population levels.
This Viewpoint discusses the use of breast density notifications to inform women with dense breast tissue of the potential need for supplemental cancer screening, as well as the need to ensure that such notifications are clear and understandable to women of all language backgrounds, literacy levels, educational levels, and socioeconomic backgrounds.
This study uses US Food and Drug Administration data and examines the association between characteristics of predicate medical devices and recall probability for applicant medical devices cleared for use via the 510(k) regulatory submission pathway.
This cross-sectional study evaluates the frequency of new devices receiving US Food and Drug Administration approval through its 510(k) pathway based on predicate devices that had been subject to a Class 1 recall.
This cohort study examines the characteristics of high-risk therapeutic devices approved by the US Food and Drug Administration for use in children and adolescents between 2016 and 2021.
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