OND re­or­ga­ni­za­tion moves for­ward

The FDA said Thurs­day that the planned re­or­ga­ni­za­tion of its Of­fice of New Drugs (OND) will move for­ward thanks to Con­gres­sion­al ap­proval, in­clud­ing changes to its Of­fice of Trans­la­tion­al Sci­ences (OTS) and the Of­fice of Phar­ma­ceu­ti­cal Qual­i­ty (OPQ).

The changes will cre­ate of­fices for in­ter­re­lat­ed dis­ease ar­eas and di­vi­sions with clear­er and more fo­cused ex­per­tise, the FDA said, not­ing the num­ber of OND of­fices that over­see its re­view di­vi­sions will in­crease from six to eight, and there will be in­creas­es in the num­ber of OND clin­i­cal di­vi­sions from 19 di­vi­sions to 27, plus six non-clin­i­cal re­view di­vi­sions.

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