FDA rais­es ques­tions with Eu­ro­pean da­ta law's re­stric­tions on re­view­ing clin­i­cal da­ta

In 2018, the EU signed off on a new law re­quir­ing or­ga­ni­za­tions to pro­tect how per­son­al da­ta is col­lect­ed or used from those re­sid­ing in the EU or its mem­ber states.

Known as the Gen­er­al Da­ta Pro­tec­tion Reg­u­la­tion (GDPR), the law has changed how com­pa­nies and on­line ad­ver­tis­ing work, but it has al­so been not-so-qui­et­ly af­fect­ing the FDA.

“So far, the FDA’s biore­search mon­i­tor­ing pro­gram (BI­MO), which over­sees the con­duct and re­port­ing of FDA-reg­u­lat­ed re­search, has been most im­pact­ed by the law,” Heather Mes­sick, a for­mer in­ter­na­tion­al pol­i­cy an­a­lyst in FDA’s Eu­rope Of­fice, who’s now a reg­u­la­to­ry coun­sel in the FDA’s Of­fice of Com­pound­ing Qual­i­ty and Com­pli­ance, wrote in a new blog post.

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