Health Canada Issues Final Guidance on 3D-Printed Implantable Devices
Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Source: The GMP Letter
Health Canada issued final guidance for devicemakers on supporting evidence required for submitting applications for 3D-printed implantable devices. Source: The GMP Letter
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. Source: Drug GMP Report
The FDA is struggling to keep inspections of facilities overseas up to par, according to a former agency investigator. Source: Drug GMP Report
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. Source: Drug GMP Report
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. Source: Drug GMP Report
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. Source: Drug GMP Report
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. Source: Drug GMP Report
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. Source: Drug GMP Report
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…
Italian regulators suspended a drugmaker’s marketing authorization following an inspection that revealed multiple serious quality violations at its facility in Cellole—about 30 miles northwest of Naples. Source: Drug Industry Daily