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

The FDA has acted on requests from users to allow data it makes available through openFDA to be downloaded. The U.S. regulator revised the system late last…

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 has started testing the precisionFDA platform it developed with DNAnexus. The closed beta test phase is the precursor to a more widespread rollout of…

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.

Over the past two years the reputation of the IT department at the FDA has changed rapidly. Once best known for burning through CIOs and receiving slapdowns…