Topic: adverse event reporting
FDA inspectors found that AbbVie didn’t include historical death complaints for the same lot in its search system for its all-too-important drug Humira.
Regeneron's Eylea has been a hit on the market for years. But now, the number of patients experiencing a rare side effect is climbing.
Even as the new administration is promising to sweep away some FDA practices to speed drugs to market, a new study has found that there has been a dramatic rise in the number of drug side effects reported in recent years.
China FDA said adverse drug event reports showed a 5.3% increase in 2015, which it hailed as a healthy signal of public awareness.