Regulatory warning for anti-epileptic drugs presents greatest threat to non-epilepsy indications (Pharmaceutical Business Review)
The FDA is close to adding a black box warning to epilepsy drugs after a safety review showed that they increase patients risk of suicidal thoughts and behavior. Datamonitor believes that, rather than impacting sales of such drugs for the treatment of epilepsy, the warning will represent a greater threat to sales of these drugs for indications where alternative drug classes are available.

Software optimizes validation life cycle management. (ThomasNet)
Through fully electronic process, ValGenesis v2.0 lets users manage entire validation life cycle. Web-based, scalable, multi-site solution enforces consistency and enhances compliance in corporate validation process. Granted 360 visibility of validation status, users can identify bottlenecks. Centralized solution also offers functionality for requirements management, traceability matrix ...