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An FDA advisory committee recommended three drug substances for inclusion to a list of approved compounding substances and shot down three others. Read More
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