Visual Podcast: FDA/Xavier Joint Initiative Aims To Help Device Firms Predict Quality Metrics
This article was originally published in The Gray Sheet
In a second Gray Sheet educational podcast, Xavier University's Marla Phillips explains a partnership between FDA and the school on a metrics initiative to identify, pilot, plan and publicize predictive quality system metrics. "We're looking at … developing a system of metrics across the total product lifecycle. In doing that, it enables companies to assess and improve the robustness of their critical-to-quality practices and, therefore, risk to product quality," she says.
You may also be interested in...
Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus.
France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.
A lower first dose boosted the vaccine’s efficacy result, but AstraZeneca has conceded that this has to be proven in a separate trial. In the meantime, the UK government has asked the regulator to assess the vaccine under a special health emergency provision.