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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
Two House Republicans are accusing the FDA of shirking its responsibility when it comes to explaining the limits of off-label promotion, leaving it up to the courts to decide the matter for it. 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
Fifteen House Democrats are calling on top U.S. trade officials to clarify the administration’s position on compulsory licensing for Novartis’ cancer drug Gleevec in Colombia. Read More