UPTON/ESHOO DEVICE REFORM BILL DESIGNED TO DRAW ATTENTION TO RISK-BASED CLASSIFICATION OF NOVEL DEVICES, FDA RECOGNITION OF CONSENSUS STANDARDS
This article was originally published in The Gray Sheet
A stand-alone device reform bill slated to be introduced by Reps. Fred Upton (R-Mich.) and Anna Eshoo (D-Calif.) on April 29 will propose provisions to allow FDA to classify novel technologies according to risk and to clarify FDA's ability to adopt consensus standards.
You may also be interested in...
Russia says it will make the first deliveries of its $10-per-dose Sputnik V vaccine in January, while international regulators say vaccine trials should continue for as long as possible to generate longer-term evidence on their benefits and risks. A UK research body has stressed that drugs repurposed for COVID-19 also need to undergo thorough safety and efficacy testing as reports suggest the UK regulator could approve a vaccine within days.
Skin hygiene is one of several categories where Edgewell Personal Care has a “right to win" after 18 months of renovations, according to the company’s 20 November Investor Day presentation. The firm has doubled its production capacity and has plans for a “full suite” of product innovation to build on Wet Ones’ 60% growth in fiscal 2020.
Considerable value has been assigned to the companies developing coronavirus vaccines. Multiple suppliers and a met clinical need may erode much of that value after the pandemic.