EMA publishes stakeholder advice on proactive data release

EMA published final advice from five groups of stakeholders on how to implement the agency's plan to proactively release clinical data for approved drugs, which is slated to go into force on Jan. 1, 2014. The agency, which currently provides clinical trial data only upon request, plans to publish a draft policy for the plan at the end of June, with a public comment period through the end of September and a final policy slated to be published at the end of November (see BioCentury, Dec. 10, 2012). ...