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Industry is asking the FDA to clarify key elements of its updated draft guidance on assessing the effects of protein-based treatments on the immune system. Read More
Brexit is unlikely to spur monumental changes for the life science industry, but regulatory compliance experts do acknowledge the possibility of many headaches. Read More
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