Postmarket Safety

Genomic Data Integral to Drug Safety Assessments, EMA Says

The European Medicines Agency is asking drug companies to keep pharmacogenomics in mind when doing pre- and postauthorization safety assessments, noting that the selection of biomarkers is key to maintaining a robust safety profile as part of pharmacovigilance activities. Read More

FDA Advisors Recommend NSAID Labeling Changes

FDA advisors want stronger warning language on labels for non-steroidal anti-inflammatory drugs, or NSAIDs, saying language added in 2005 is not strong enough and may lead doctors and patients to think there is no risk of cardiovascular (CV) blood clots in short term use of the drugs. Read More