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A comprehensive readiness plan for an FDA inspection includes thorough knowledge of your document archiving and transfer procedures, according to an FDA inspections expert speaking at the WCG FDAnews Annual FDA Inspections Summit in Washington, D.C., Nov. 16-18. Read More
A retrospective analysis of Masimo SET pulse oximetry readings in healthy Black and White volunteers showed no clinically significant bias due to skin pigmentation, the company said, citing a study reported in the Journal of Clinical Monitoring and Computing. Read More
Complete document archives with self-explanatory file names are the top two — out of the top 10 — ways to be prepared for an FDA inspection, advised an FDA inspections expert at the WCG FDAnews Annual Inspections Summit in Washington, D.C., Nov. 16-18. Read More
SpaceX’s upcoming resupply mission to the International Space Station (ISS) National Laboratory will test the viability of a new remote-controlled drug delivery implant to provide extended, adjustable medication from afar. Read More
Philips Respironics has informed the FDA of two new potential issues with its reworked Trilogy ventilators that were part of a June 2021 recall. Read More