The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more
Laboratory Developed Tests -
After many years of promising that it would be providing guidance on the regulation of laboratory developed tests (LDTs), the Food and Drug Administration (FDA) provided notice to Congress...more
In what has been an active couple of months of released guidance documents, the FDA issued another draft guidance on June 20, 2014 entitled, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image...more