Navidea Biopharmaceuticals Submits Lymphoseek Marketing Authorization Application to European Medicines Agency
This paragraph is also very important:(Good for our FDA)
"It is also important to note that, as part of the normal MAA filing process, the EMA required good manufacturing practices (GMP) pre-submission inspections at the Lymphoseek contract manufacturing facilities. These inspections were recently successfully completed by independent auditors from the European Union (EU), thereby enabling our MAA filing,” commented Dr. Mark Pykett, President and CEO of Navidea. “We are encouraged by these positive pre-submission manufacturing audits which we believe bode well for Lymphoseek’s ultimate commercialization. "
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