The FDA’s ad police warned a Campbell, Calif.-based company to stop claiming that its prescription diet pill can help patients lose weight three times faster than diet and exercise alone.…

As part of its ongoing enforcement efforts against drug compounders, the FDA plans to move the program’s base of operations from CDER’s Office of the Center Director to the Office…

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…

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