We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The firm attributed out-of-specification and out-of-trend assay results for certain tablets to sampling preparation errors but didn’t provide any evidence to support the findings. Read More
The assay is also approved to test plasma or serum samples to screen other living or dead organ donors and human cells, tissues and cellular and tissue-based products. Read More
The in-person study will consist of an hour-long 40-person pilot study, in addition to two hour-long studies with 200 voluntary participants each. Read More
Some pharmacies “billed extremely high amounts” for at least one of five measures that OIG has developed as indicators of possible fraud, waste or abuse. Read More
The FDA faulted the Siemens facility for not properly verifying the accuracy of the reagent expiration dates its software calculated and generated. Read More
Sponsors are required to submit the guides in cases where certain information is necessary to prevent adverse effects and where adherence to directions is essential to a drug’s effectiveness. Read More