Bio­phar­ma com­pa­nies to FDA: In­ter­na­tion­al­ly har­mo­nize plans to stan­dard­ize safe­ty da­ta and analy­sis

As the FDA push­es to more broad­ly stan­dard­ize the way it col­lects safe­ty da­ta to bet­ter de­tect con­cern­ing sig­nals with phar­ma­ceu­ti­cals, bio­phar­ma com­pa­nies are push­ing back on why there isn’t a more in­ter­na­tion­al ap­proach giv­en the glob­al na­ture of the in­dus­try.

The cur­rent lack of stan­dard­iza­tion around the analy­sis of pre­mar­ket safe­ty da­ta and vi­su­al­iza­tion in ap­pli­ca­tions has led to the FDA ac­knowl­edg­ing that there have been in­con­sis­ten­cies in ad­verse event de­f­i­n­i­tions, cat­e­go­riza­tions, analy­ses, and pre­sen­ta­tions.

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