The agency hopes the adoption of electronic informed consent measures could help participants retain and understand information as well as allow quicker timing of updates.
FDA Draft Guidance on General Wellness Devices: A Primer
The FDA’s proposed upgrade to its off-label distribution guidelines has some new features, but experts say it is unclear if this means more dollars will flow toward reprints.
The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don’t work correctly.