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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