The FDA has partnered with Flatiron Health to assess the use of real-real world data to demonstrate the safety and efficacy of cancer immunotherapies.

FDA has posted draft guidance designed to facilitate the use of data from EHRs to back up claims about the safety and efficacy of experimental drugs.

Stallergenes Greer has poached an IT exec from Pfizer spinoff Zoetis as it looks to bounce back from a tech implementation that forced the shutdown of a plant.

J. Craig Venter's Human Longevity, Inc. has refueled in the race to build an industry-leading repository of genomes and associated data. The refueling…

Danish drug developer Lundbeck has upgraded to the latest version of ArisGlobal's regulatory and safety platform. The decision, which follows a review of…

Bristol-Myers Squibb has struck a deal with Veeva Systems to access tools for the management of its regulatory information. The agreement will see Bristol-…

The resulting paper, which was coauthored by staffers at the Department of Health and Human Services (HHS), found clinical procedure costs were the top cost…

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.

Regulatory