The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
FDA released the framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development on March 23, 2023. The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.
The DHT program will:
Further, DHTs can help conduct decentralized clinical trials, where data can be remotely recorded and analyzed directly from participants as a part of everyday tasks at places such as school, home, work, or outdoors. DHTs can also benefit with data collection from participants who are unable to report their experiences, like infants or cognitively impaired individuals. This kind of data collection can expand access to underrepresented and diverse patient populations and improve trial retention rates by improving convenience for trial participants and reducing caregiver burden.
Source: FDA
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.