Biomaterials legislation
This article was originally published in The Gray Sheet
Executive Summary
The Health Industry Manufacturers Association is planning to propose legislation designed to keep firms from exiting the biomaterials supply business, HIMA president Alan Magazine said at a March 30 session of the association's annual meeting. HIMA says the proposal will suggest "tort reform" for cases involving materials used in medical devices. The HIMA initiative was prompted by announcements by Dow Corning and DuPont that they will cease supplying materials for medical implants. HIMA says it is concerned that additional materials suppliers also may withdraw from the medical device market. FDA has set up a system intended to expedite review of substitute materials for Dow Corning's implant-grade silicone ("The Gray Sheet" March 15, I&W-1). However, some implant firms believe that high-quality substitute materials may not be currently available.
You may also be interested in...
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.
Over The Counter 2 Apr 2024: Analyzing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen
In this episode, HBW Insight’s Europe and US editors bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago; Kenvue, soon to celebrate its first anniversary as a new company; Sanofi Consumer Healthcare, which is poised to split from its pharma parent; and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.