FDA Stresses Human Factors Design For Home-Use Devices
This article was originally published in The Gray Sheet
Executive SummaryFDA is emphasizing the need for human factors engineering as products continue to migrate from the clinical setting to the home
You may also be interested in...
Companion diagnostics are needed increasingly by pharma companies to justify the safety and effectiveness of their products. With specific first-time EU regulation of these products within sight – and urgently needed – is there a risk of delays to these products being able to demonstrate compliance?
Draft policy moots crowdfunding for high-cost rare diseases alongside financial support for those "amenable to one-time treatment" but falls way short of some patient groups' expectations.
India’s Hilleman Laboratories says it’s aiming to develop an affordable vaccine that will target pregnant women in low- and middle-income countries to prevent Group B Streptococcus, a potentially fatal infection passed to babies during childbirth.