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The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
Sponsors of new drugs seeking marketing authorization in the EU must now apply to receive a numerical code unique to the application, the European Medicines Agency (EMA) said Tuesday. Read More
Three prominent Republican senators have added their voices to the growing number of critics attacking the FDA’s decision last year to approve Zogenix’s high-dose opioid Zohydro ER. Read More
The U.S. Department of Justice wants to rid the pharmaceutical industry of pay-for-performance sales compensation packages, believing they fuel fraud, off-label marketing and other deceptive behaviors, a former top prosecutor says. Read More
The European Medicines Agency is following in step with U.S. regulators and, at the request of Sweden’s medicines authority, is reviewing the efficacy of emergency contraceptives in heavier women. Read More
Drugmakers should be careful not to use language in product labeling that could be considered promotional, such as comparisons with an alternate treatment, a Health Canada final guidance says. Read More
The Pharmaceuticals and Medical Devices Agency is asking drugmakers to submit information on stability monitoring and water purity when they apply for mandatory postapproval good manufacturing practice inspections. Read More
Drugmakers should clearly define their validation activities in a validation master plan that accounts for the lifecycle of a product and related plant equipment, the European Commission says. Read More