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With more than 80 percent of APIs coming into the U.S. from foreign sites, FDA is stepping up its enforcement activities to better manage global supply chains. At the same time, India and China are also expanding their inspection teams. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
The FDA and the European Medicines Agency are working to increase regulatory collaboration, including harmonizing their respective pharmacovigilance and quality by design programs, officials from both agencies said June 18. Read More
The FDA wants manufacturers to better control the amount of excess drug or biologic they put in injectable vials and ampules to ensure proper patient dosing. Read More
The Office of Pharmaceutical Quality’s “One Quality Voice” is “well on its way to becoming a reality,” CDER Director Janet Woodcock said June 17. Read More
Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says. Read More
A panel of judges from the Federal Circuit Court of Appeals has ruled that two of The Medicines Company’s patents for its anticlotting drug Angiomax are invalid — a win for Hospira, which is planning a generic version of the treatment. Read More
The U.S. government and 11 states are seeking as much as $3.3 billion from Novartis over an alleged kickback scheme involving its Exjade and Myfortic drugs, according to documents filed in the U.S. District Court for the Southern District of New York. Read More
The FDA is cracking down on companies that manufacture or distribute unapproved prescription ear drops labeled to relieve pain, infection and inflammation, warning they will be subject to seizures, injunctions and criminal proceedings. Read More