Regulatory Affairs

EU Industry Calls for More Dialogue on Proposed Pharmacovigilance Fees

While manufacturers support a strong pharmacovigilance system to ensure patient safety, the proposed costs are a source of concern, “especially in light of the annual saving for the pharmaceutical industry of 145 million euros (US $201 million) that was anticipated in the 2008 European Commission ‘impact assessment,’” a coalition of five trade groups says. Read More

Ben Venue Recalls Acetylcysteine Solution

Ben Venue is working with the FDA on a recall of its acetylcysteine solution 10 percent USP after a single glass particle was found in just one vial of a lot of the drug, the company said last month. Read More

EMA Launches RMP Transparency Pilot

The European Medicines Agency (EMA) on Mar. 11 launched its latest transparency effort, publishing the first of many summaries of drugmakers’ risk management plans (RMP) that it plans to make available throughout 2014. Read More

EMA Seeks to Increase Quality of Immunogenicity Studies

A European Medicines Agency working group is recommending revisions to a guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins to account for differences between large complex and small, simple-structured proteins and other critical issues. Read More