FDA Warns Of Possible Counterfeit Materials In Boston Scientific Mesh
This article was originally published in The Gray Sheet
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...
Aker BioMarine seeks supplement firms to use its EPA/DHA innovation bound by lysophosphatidylcholine to enable the fatty acids to pass through the blood-brain and blood-retinal barriers and boost of eye and brain health benefits. It will submit an NDI notificaion in the US during 2022.
The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.
Commissioner Hahn’s tweet announcing a return to inspections, while not a new policy, may be signal that FDA understands sponsor concerns with the agency’s limited ability to conduct onsite inspections. Effort may be aimed at reassuring industry even as CRLs related to manufacturing increase.