On 24 March 2023, a notice was published in the Federal Register announcing that the Food and Drug Administration published a framework for the use of digital health technologies (DHTs) in drug and biological product development. DHTs are systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses. FDA previously published draft guidance identifying considerations for the use of DHTs to support clinical investigations and relating to different aspects of DHT use. In the draft guidance, FDA particularly highlighted the importance of verification and validation to ensure the DHTs are for fit-for-purpose for use in the clinical investigation. Further, remote data acquisition through DHTs may raise issues including data privacy and confidentiality concerns.

The US Food and Drug Administration ensures the quality of drug products by carefully monitoring both domestic and foreign drug manufacturers’ compliance with its Current Good Manufacturing Practice regulations. With over 350 manufacturing establishments supplying the US drug market, China represents one of the two countries with the most foreign drug establishments subject to FDA inspection.

The US Food and Drug Administration ensures the quality of drug products by carefully monitoring both domestic and foreign drug manufacturers’ compliance with its Current Good Manufacturing Practice regulations. With over 350 manufacturing establishments supplying the US drug market, China represents one of the two countries with the most foreign drug establishments subject to FDA inspection.