EMA Updates Flu Vaccine Recommendations
The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.
On April 30, 2018, the European Medicines Agency (EMA) updated the European Union list of recommendations for influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season. The update contains a decision on suitable strains for live, attenuated vaccines. EMA also updated the list of reagents for vaccine standardization.
The ad-hoc Influenza Working Group initially made recommendations for the 2018/2019 flu vaccines on March 26, 2018. The list is developed on the basis of recommendations by the World Health Organization.
Applications to change the composition of centrally authorized flu vaccines are due by June 18, 2018.
Source: EMA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
