Biologics

Remote Data Digital Health Guidance

FDA has published a draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, with recommendations for sponsors, investigators, and other interested parties on the use of digital health technologies for remote data acquisition from participants in clinical investigations evaluating medical products. The document defines a digital health technology as a system that uses computing platforms, connectivity, software, and/or sensors for healthcare and related uses.

The guidance says it outlines recommendations intended to facilitate the use of digital health technologies in a clinical investigation as appropriate for the evaluation of medical products.

The recommendations address:

the selection of technologies that are suitable for use in the clinical investigation;
verification and validation of technologies for use in clinical investigations;
use of digital technologies to collect data for trial endpoints;
identification of risks associated with the use of digital technologies during the clinical investigation; and
management of risks associated with using digital health technologies in clinical investigations.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome