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The House Appropriations committee approved nearly $3.3 billion in spending for the FDA for fiscal year 2020 and once again nudged the agency to get going on its delayed continuous manufacturing initiative. Read More
The FDA flagged four U.S. facilities and one in Switzerland for quality and other violations observed during agency inspections—from inadequate testing to incomplete records. 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
The FDA issued warnings to one Indian drugmaker, one Canadian manufacturer and four U.S. facilities for a variety of violations including falsified or missing data. 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
Italian regulators suspended a drugmaker’s marketing authorization following an inspection that revealed serious quality violations at its facility in Cellole—about 30 miles northwest of Naples. 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
Outgoing FDA Commissioner Scott Gottlieb highlighted plans for drug compounding enforcement among the agency’s drug priorities in his final testimony before House appropriators on April 3. Read More
EU regulators flagged 18 percent of inspected biologics and nine percent of inspected drugs for scientific or regulatory problems in the two decades since European regulators began inspecting drugs and medicines, the European Medicines Agency said in a new report. Read More