Whether subjects can use their own personal devices, how to manage mid-study technology updates, and the extent to which data gathered will be shared with patients in real-time are all issues that sponsors, investigators and regulators need to consider.
Digital health technologies hold tremendous promise in drug development, including bringing clinical trials to patients and providing a more consistent, and less intrusive, assessment of function and disease impacts.
However, sponsors, investigators and regulators must weigh a host of practical considerations when deciding whether and how to build digital...
Agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
The current regulations were written when clinical trials involved far fewer entities, and a certain amount of ‘contortion’ is necessary when sponsors are trying to introduce decentralized, community-based and other modern elements, the FDA’s Kevin Bugin says in an interview with the Pink Sheet.
Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’
While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
