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In the next few years, drugmakers will have to collect quality metrics data for FDA investigators to use in determining a facility’s quality status. Metrics being bandied about include batch failure rates, CAPA rates, complaints and right-first-time rates. Read More
The FDA has established a public docket so that compounding pharmacies and others can share their experiences and views regarding the agencies drug compounding regulations. Read More
UK regulators shut down a plant in Cambridgeshire that was producing an unapproved and unlicensed product used against diseases such as HIV and cancer. Read More
The South Carolina Supreme Court more than halved the $327 million in penalties imposed on Johnson & Johnson’s Janssen drug unit by a lower court for hiding the risks of its drug Risperdal, ruling that the penalties levied on the company were excessive. Read More
Quality problems at an India contract manufacturer are prompting Sagent Pharmaceuticals to recall its injectable atracurium besylate and shift manufacturing of the drug to its U.S. facility, leading to a likely shortage of the product. Read More
A New Jersey-based drug compounder and two of its top corporate officials have been indicted on fraud charges for repackaging and distributing unsterile drugs to several states. Read More
The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, becoming another Indian facility to get a warning letter for data integrity violations. Read More
The FDA warned that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
The U.S. Food and Drug Administration warned last month that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More