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The California company received complaints about patients who required prescription antibiotics for pin site infections developed while being treated with the Digit Widget device. Read More
An agency investigator found three complaints regarding devices that were returned to Cadwell more than a year ago that had not been evaluated. Read More
Foundation Medicine’s F1CDx can detect mutations in as much as 324 genes and two genomic signatures by sequencing DNA in solid tumor samples in a single test. Read More
The new guidance provides details on the clinical trial data needed to assess safety and efficacy of medical devices and in vitro diagnostics intended for registration in China. Read More
Assessors should include information about the drug substances’ general properties and physical characteristics, plus solubility in solvents involved in manufacturing or cleaning processes. Read More