The White House has released a security framework to help organizations participating in the Precision Medicine Initiative protect information on individuals.

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FDA has posted draft guidance designed to facilitate the use of data from EHRs to back up claims about the safety and efficacy of experimental drugs.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

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

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…

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