Regulatory Agencies

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 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 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.