[1] Hlth Canada, Ottawa, ON K1A 0K9, Canada
[2] US FDA, Silver Spring, MD 20993 USA
[3] US FDA, St Louis, MO 63110 USA
[4] Hlth Sci Author HSA, Singapore 138667, Singapore
[5] Agencia Nacl Vigilancia Sanit ANVISA, Brasilia, DF, Brazil
[6] European Med Agcy EMA, EU, Amsterdam, Netherlands
[7] Bundesinst Arzneimittel & Med Prod BfArM, Bonn, Germany