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June 04, 2014
EMA publishes revised guideline on the acceptability of names for drugs.
May 30, 2014
FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.
May 20, 2014
FDA issues complete response letter for Novartis' RLX030 for acute heart failure.
May 15, 2014
EMA opens registration for it's sixth annual workshop on pediatric drug research and development.
EMA and ECHA sign agreement to share information and work together on risk assessments.
May 14, 2014
Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.
May 02, 2014
The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.
April 30, 2014
The European Medicines Agency's Annual Report highlights drug approvals, projects, and initiatives for 2013.
April 14, 2014
EMA sends its results on Roche investigation of pharmacovigilance non-compliance to the European Commission.
March 31, 2014
GSK recalls alli weight loss products in the US and Puerto Rico.