FDA-APPROVED PRODUCTS WOULD BE SHIELDED FROM LIABILITY UNDER HOUSE MEDICARE BILL; BIOMATERIALS LIABILITY PROTECTION, BREAST IMPLANT CARVE-OUT EXCLUDED
This article was originally published in The Gray Sheet
Health care liability language in the House Ways and Means/Health Subcommittee Medicare bill shields manufacturers from product liability claims if the product "was subject to premarket approval by [FDA] with respect to the safety of the formulation or performance" and when "such drug, device, packaging or labeling was approved by" the agency.
You may also be interested in...
Top 100 Review: The Calm Before The Storm – But Some Medtechs Already Reflect The Ravages Of COVID-19
2019 saw fewer revenues-boosting major acquisitions by top-tier medtechs. Companies that reported after the calendar year-end were the first to see the consequences of the pandemic on their annual figures.
Hikma and Sesen Bio have struck a deal that will see Hikma distribute the Vicineum brand in the MENA region.
By establishing a dedicated consumer healthcare subsidiary, Norgine is hoping it can grow its $200m-plus Movicol laxative brand and take advantage of M&A opportunities in the OTC market.