Drug Approvals

Much has been said in the news regarding drug recalls such as this latest article from NY Times, where they discuss how certain drug imports from an Indian drug maker have been stopped. Also, as we mentioned yesterday, one tool CROs can use are LIMS to help with the authorization processes set in place by regulatory agencies. In relation to these news items, PharmaVoice mentions here, that there is a real need for technology to be updated in order to combat drug safety concerns. As of September 2007, the FDAA was updated to require certain sponsors to submit a “proposed REMS”. In addition, the EU is requiring a PSURs to be submitted every 6 months for the first 2 years. The PharmaVoice article summarizes:

“This will require companies to invest in more advanced pharmacovigilance technologies and to develop new processes for the analysis of adverse events both in the postmarketing environment and during development.”