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To simplify the Institutional Review Board review process, the National Institutes of Health is requiring a single IRB to oversee multi-site research of non-exempt human subjects funded by the institute. Read More
The European Medicines Agency recommendations for drug approvals saw a steady uptick in 2015, even as the number of new active substances fell slightly. 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 Indian court is ordering Pfizer to honor an earlier promise to dump large quantities of its steroid Medrol prior to the drug’s expiration date. Read More
France is tightening restrictions on early-phase clinical trials in the wake of one study that left one patient brain-dead and hospitalized five others. Read More
European regulators are proposing a series of indirect methods for driving down prescription drug costs without stepping outside the science-focused parameters of their roles. Read More
Generic trade groups and patient advocacy organizations are taking competing stances in their recommendations for the FDA’s biosimilar labeling draft guidance. Read More