FDA, Health Canada ap­prove iso­tope im­ports from Poland

Modern Healthcare - - Late News -

The Food and Drug Ad­min­is­tra­tion and the Cana­dian reg­u­la­tory agency Health Canada have each ap­proved the im­por­ta­tion of molyb­de­num-99 from the War­saw, Poland-based Maria Re­search Re­ac­tor for use in pro­duc­ing the imag­ing iso­tope tech­netium-99m, ac­cord­ing to a news release. The ura­nium byprod­uct will be im­ported and used by med­i­cal sup­ply com­pany Co­vi­dien, Mans­field, Mass., to pro­duce the iso­tope, which is used in ap­prox­i­mately 80% of all nu­clear di­ag­nos­tic tests. The iso­tope has been in short sup­ply since the shut­down of Canada’s Chalk River re­ac­tor in Fe­bru­ary 2009 and sub­se­quent main­te­nance-re­lated shut­downs of other re­ac­tors around the globe. The ar­range­ment is ex­pected to sup­ply enough iso­topes to pro­duce 1 mil­lion imag­ing stud­ies world­wide over the next six months.

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