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The European Medicines Agency’s pharmacovigilance committee revised its methods for measuring the health outcomes of its major regulatory interventions, aiming to improve industry safety monitoring practices and find out which activities have been the most successful. Read More
The European Medicines Agency launched the new version of its EudraVigilance adverse event database Nov. 22, providing more tools for analysis. Read More
The FDA launched a new search dashboard for its adverse event reporting database, promising a more user-friendly method for industry and the general public to access the agency’s safety and surveillance data. Read More
The European Medicines Agency added answers to 60 new questions in its list of inquiries from stakeholders regarding the launch of its new EudraVigilance drug safety reporting program. Read More
The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Read More
The European Medicines Agency should upgrade its user testing of drug packaging inserts and other product information for patients over the next 18 months in carrying out recommendations from the European Commission, the agency said in an action plan. Read More
Drug wholesaler Amerisourcebergen agreed in federal court to pay $260 million and plead guilty to violating drug laws via a criminal scheme to sell cancer drugs illegally repackaged in pre-filled syringes. Read More
Federal administrators of the Medicare Part D prescription-drug program should expand their oversight of opioid prescriptions and focus their surveillance of potential drug abuse more tightly on opioids, the U.S. Government Accountability Office said in a report. Read More
GAO researchers found that medication-assisted treatment can be more effective in reducing opioid use and reducing program dropouts than abstinence-based treatment. Read More