Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic.

Introduction: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials. Regulatory units within an Academic Medical Center (AMC), including those part of the Clinical and Translational Science Award (CTSA) consortium, have provided support for clinicians in navigating these options prior to the pandemic. As such, they were positioned to be a resource for accessing therapies during the COVID-19 public health emergency.

Regulatory Considerations in the Design and Manufacturing of Implantable 3D-Printed Medical Devices.

Three-dimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3D-printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval.

Scarcity of HIV/AIDS risk-reduction materials targeting the needs of older adults among state departments of public health.

This study investigated the availability of printed human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) education/prevention materials from state departments of public health within the United States, which specifically targeted the older adult population. Information on HIV/AIDS from public health departments in each of the 50 states was solicited, obtained, and analyzed for applicability to an older adult population. Although all 50 states responded to our request for publications, only 15 states (30%) provided publications that were specifically intended for an older adult audience.