> "The case of rosiglitazone underscores the need for a robust evidence base to demonstrate the safety of medicines administered long-term," write Margaret Hamburg and FDA co-authors in the New England Journal of Medicine, of the limitations of the meta-analyses and observational studies conducted on Avandia. Article
> GlaxoSmithKline has until next month to tell the FDA how it plans to investigate concerns of bias in the Record trial the drug giant ran for Avandia, reports the Financial Times. Article
> NIH is funding Mi-Co to develop a digital-pen-based solution for more efficient capture of medical oncology progress notes and clinical trials data. Release
> Oracle has taken the wraps off Agile Product Lifecycle Management (PLM) 9.3.1 for pharma drug development. Release
> CRO Beardsworth will implement the OmniComm AE Reporting System. Release