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A New York maker of homeopathic medicines that include toxic ingredients ran afoul of the FDA because it made drug-like claims for its products but did not manufacture them to the standards invoked by the claims, the agency said in a warning letter. Read More
The FDA outlined plans coordinating CDER and the Office of Regulatory Affairs in inspecting manufacturing facilities seeking approval for new pharmaceuticals. Read More
The FDA cited a Chinese drug and API facility for a slew of violations of agency standards, based on an inspection of the company’s plant in Tianmen. Read More
The European Medicines Agency conducted 15 percent more inspections for compliance with good clinical practices in 2016 than in 2015, the agency reported. Read More
The FDA has outlined plans for coordination between CDER and ORA in checking out the manufacturing facilities of drugmakers seeking approval for new pharmaceuticals. Read More
The FDA has agreed to fully share information from its inspections of drug manufacturers with its European Union counterparts, including for the first time trade secrets, the agencies announced. Read More
The FDA cited two compounders and two drugmakers for failure to maintain aseptic conditions and for other shortcomings, as reflected in Form 483 inspection reports. Read More
Drugmakers in Canada, China, the Philippines and several American states received warning letters for a variety of GMP missteps, and some of the foreign operators were slapped with import bans. Read More
The European Medicines Agency conducted 15 percent more inspections for compliance with good clinical practices in 2016 than in 2015, the agency reported. Read More