The European Medicines Agency launched the new version of its EudraVigilance adverse event database Nov. 22, providing more tools for analysis. 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

Most drugmakers are fulfilling their postmarketing study commitments, but many are not meeting their deadlines for annual status reports, the FDA said. Read More

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