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After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today. Read More
The FDA smacked Samsung Biologics for using technology to support application submission testing that had inadequate data integrity controls, among other lapses, following an inspection of its Incheon, South Korea, facility conducted in August and September. Read More
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, according to a high-ranking agency official. Read More
The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More
A Chinese heparin contract testing lab has been warned by the FDA for significant cGMP violations, recalling unresolved questions and concerns from the Chinese heparin scandal a decade ago. Read More
A federal judge has barred an Alabama compounder from manufacturing, holding or distributing drugs until the facility complies with FDA regulations. Read More
The FDA sent warning letters to four compounding pharmacies, reminding them of their obligations under federal law to compound drug products based on valid prescriptions, while one compounder told the agency it was exempt from the FDA’s GMP requirements. Read More
The FDA found substantial sterility problems on a visit to Kansas-based ARJ Infusion Services, makers of in-home intravenous medications for adults and children with rare and chronic conditions. Read More