Aca­d­e­mics and re­searchers raise con­cerns with FDA’s plan for ‘in­te­grat­ed re­views’

More than 50 aca­d­e­mics and re­searchers from Har­vard, Yale, Johns Hop­kins and oth­er uni­ver­si­ties around the world are call­ing on the FDA to not re­place its orig­i­nal re­views of med­ical prod­ucts with an “in­te­grat­ed re­view” be­cause of the valu­able in­for­ma­tion that would be lost.

The re­searchers claimed that such a shift would de­prive them of in­for­ma­tion and da­ta on the clin­i­cal stud­ies and tri­als sub­mit­ted to the FDA, in­for­ma­tion on the post­mar­ket­ing re­quire­ments, and re­view­er con­cerns with an ap­pli­ca­tion that might not be in­clud­ed in a sum­ma­ry doc­u­ment like the in­te­grat­ed re­view, among oth­er im­por­tant de­tails.

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