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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
California’s HeartVista has teamed with Germany-based Siemens Healthineers to co-market an automated cardiac magnetic resonance (CMR) imaging exam platform that takes up less scanner time and requires no additional training for technicians. Read More
The integrity of manufacturers’ data is a major focus of FDA inspections and the agency’s investigators will go to great lengths to uncover problems, three former FDA inspection officials told attendees at the WCG FDAnews 17th Annual FDA Inspections Summit in Washington, D.C. last week. Read More