FDA, EU au­thor­i­ties up­date guid­ance on clin­i­cal tri­als dur­ing Covid-19

The EMA on Tues­day up­dat­ed their guid­ance on man­ag­ing clin­i­cal tri­als dur­ing the Covid-19 pan­dem­ic, adding ad­vice on dis­tri­b­u­tion, da­ta ver­i­fi­ca­tion and com­mu­ni­cat­ing with au­thor­i­ties.

The up­dat­ed guid­ance fol­lows a re­cent sim­i­lar up­date from the FDA, which added sev­en new ques­tions and an­swers to its doc­u­ment.

Eu­ro­pean Com­mis­sion guid­ance

The up­date marks the third ver­sion of the guid­ance from the Com­mis­sion, EMA and the Heads of Med­i­cines Agen­cies and pro­vides new rec­om­men­da­tions on the dis­tri­b­u­tion of in­ves­ti­ga­tion­al med­i­c­i­nal prod­ucts (IMPs) and da­ta ver­i­fi­ca­tion un­der so­cial dis­tanc­ing mea­sures and re­source lim­i­ta­tions.

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