Executive Briefing Series (formerly The Food & Drug Letter)

May 4, 2012

Joint Postmarket Study Possible To Allay Broader Safety Concerns

The European Medicines Agency (EMA) could require multiple drugmakers to conduct a joint post-authorization safety study (PASS) if concerns about the risk of a particular compound apply to more than one drug, according to the agency.

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FDA Adopts ICH’s Alternative Benefit-Risk Reporting Program Industry Calls for EMA Restraint in Postauthorization Efficacy Studies Updated EU Distribution Guidelines Push Internal Audits to Ensure GDP FDA Adopts ICH’s Alternative Benefit-Risk Reporting Program

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