Roche May Face Fine in EU Over Alleged Pharmacovigilance Shortfalls

The European Medicines Agency (EMA) has initiated its first-ever infringement procedure against a drugmaker, alleging Roche did not report potential adverse events for 19 of its U.S. drugs.

To View This Article:


Subscribe To International Pharmaceutical Regulatory Monitor

Buy This Article Now

Add this article to your cart for $40.00