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EMA is reviewing its guidelines for Phase 1 trials in the wake of a fatally flawed French study, with an eye toward issuing proposed revisions in July. Read More
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read More
An FDA advisory committee recommended approval of Sanofi’s combination candidate for Type 2 diabetes Wednesday, making it the second such product backed by the committee in the last 24 hours. Read More