FDA Warns Of Possible Counterfeit Materials In Boston Scientific Mesh
This article was originally published in The Gray Sheet
Executive Summary
The company changed suppliers of a plastic resin called Marlex in 2011, and FDA is investigating allegations that resin from the new supplier wasn’t properly tested for safety. The FDA safety alert closely follows a citizen petition requesting that mesh made with the resin be recalled on the same grounds. However, Boston Scientific says the resin was tested and proven to be safe.
You may also be interested in...
Alvotech Highlights Lack Of Simponi Rivals As It Delivers Golimumab Results
Alvotech has just become the first company to announce positive topline results from a confirmatory clinical study for a proposed golimumab rival to Simponi and Simponi Aria – and moreover, the firm sees limited competition from other biosimilars on the horizon.
Xbrane Assembles The Troops As FDA Says No To Lucentis Biosimilar
Xbrane Biopharma was riding the crest of a wave with the EU launch of its biosimilar to Lucentis, following years of toil and investment. However, plans to roll out the product in the US will have to be pushed back – likely – into the middle of 2025, following a US FDA complete response letter.
UK MHRA Updates Assistive Tech And Borderline Regulations
Device classification themes were uppermost in April for the UK regulator, which issued key guidance in two areas prone to complexities. It also contributed to the MedTech Directorate’s one-year progress report.