BIO, Al­ler­gan and Roche call for FDA flex­i­bil­i­ty with pa­tient ex­pe­ri­ence da­ta

In­dus­try group BIO and bio­phar­ma com­pa­nies Al­ler­gan and Roche are call­ing for the FDA to be flex­i­ble in its ap­proach for us­ing pa­tient ex­pe­ri­ence da­ta (PED) and in al­low­ing the use of such da­ta in la­bel­ing.

BIO said that it “strong­ly be­lieves” that in or­der for a broad adop­tion of PED, any up­com­ing guid­ance doc­u­ments on pa­tient-fo­cused drug de­vel­op­ment “should em­pha­size the FDA’s will­ing­ness to ex­er­cise reg­u­la­to­ry flex­i­bil­i­ty and ac­cep­tance of in­no­v­a­tive de­signs and ap­proach­es for col­lect­ing PED.”

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