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The FDA took a victory lap after a federal judge agreed to shut down a pair of Florida stem cell clinics, but the agency made clear that it won’t rest on its laurels and is now focused on its ongoing contest with a Beverly Hills surgeon over unapproved stem cell therapies. Read More
Illinois-based compounder PharMedium Services has been ordered to shut down operations at its Tennessee site after repeated warnings from the FDA to clean up its act. Read More
A federal judge has ordered a Texas drug compounder to cease all operations after failing to respond to warnings from the FDA about insanitary conditions. Read More
Health Canada is increasing fees for drug sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes. Read More
The World Health Organization released draft guidelines advising regulators to test the wastewater of drug plants to keep antibiotics out of the environment—and it says wastewater treatment should be part of good manufacturing practices. Read More
Wealthy nations with big pharma industries—in particular, Denmark, Germany, Japan, Australia and the U.S.—fought fiercely against the draft recommendation. Read More
Leading drug manufacturers and trade groups are calling for modifications to the FDA’s draft guidance on continuous manufacturing quality considerations. Read More