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Janssen has moved to a continuous manufacturing process at one of its facilities after getting the green light April 8 from the FDA to switch from batch production, making it the first drugmaker allowed to change its production method mid-cycle. Read More
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