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FDA's Justina A. Molzon on ICH and Harmonization
December 3rd 2009Pharmaceutical Technology talks to FDA's Justina A. Molzon about current discussions with international regulators, and how, after 20 years of harmonization activities and the common technical document, ICH has benefited regulatory authorities.
EMEA reaffirms safety of pandemic vaccines
November 27th 2009After further reviewing data on the H1N1 pandemic vaccines approved in Europe, the EMEA has reaffirmed their balance of benefits and risks in the context of the current H1N1 influenza pandemic. Additionally, the World Health Organization (WHO) has issued an update on the H1N1 situation in Europe.