The deal gives DNAnexus a starring role in the creation of precisionFDA, an open-source platform the FDA sees as a way to manage the anticipated surge in the…

For the first time, the FDA has approved a drug produced using a 3D printer. Aprecia Pharmaceuticals picked up the approval and distinction of being first past…

A congressman is taking aim at perceived flaws in FDA's long-awaited, much-discussed guidance on the use of Twitter.

The FDA has overhauled its Risk Evaluation and Mitigation Strategies website to make it easier to find up-to-date information. The new version moves details of…

The FDA has challenged developers to create algorithms that identify spikes in adverse event data automatically. The challenge is one of several posted by the…

Sanofi is suing startup Diagnosia over the publication of information about side effects and drug interactions in its physician decision support software.

Analysts at MarketsandMarkets have looked into their crystal ball and come up with a forecast of the pharmacovigilance and drug safety software sector. The…

Having faced years of criticism for its failure to publish guidelines on how the industry can use social media, the FDA is now being chastised by the advocacy…