The congressional watchdog has taken the FDA to task over the IT system it uses to track the safety of approved drugs. Officials at the Government…

The genomic testing lab was accused of providing kickbacks to healthcare providers in return for patient referrals.

FDA has hit the tight timeline it set itself for the start of the precisionFDA open beta program. The system went live this week, just as the regulator…

The regulator, which has faced criticism in the past over its failure to establish a policy, set out its position in a 12-page document.

The FDA is trying to learn more about virtual clinical trials, the bring-your-own-device (BYOD) model of provisioning and other aspects of today's tech…

The software, called PKPlus, is seen by Simulations Plus as a way to step up competition in the market for noncompartmental analysis software.

BioClinica is continuing the rapid evolution that began 18 months ago when its new owners merged it with CCBR-SYNARC. The latest step in the process is the…

The FDA has come good on its promise to make its stash of medical device data available publicly.