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FDA has posted draft guidance designed to facilitate the use of data from EHRs to back up claims about the safety and efficacy of experimental drugs.

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…

Over the past few years, regulators have frequently found fault with data integrity at manufacturers and CROs, which have been accused of everything from…

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