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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Leading drug manufacturers and trade groups are calling for modifications to the FDA’s draft guidance on continuous manufacturing quality considerations.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
The FDA should publish a rulemaking notice on the roles that third-party companies play in the security of the nation’s drug supply “without delay,” the House Appropriations Committee said Monday ahead of a vote on the agency’s fiscal year 2020 budget. Read More