Robert Califf, FDA Comissioner (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Good clin­i­cal prac­tices: FDA opens up­dat­ed ICH draft guid­ance for com­ments

The FDA this week re­leased new draft guid­ance that aims to mod­ern­ize clin­i­cal tri­als, with an up­date to the In­ter­na­tion­al Coun­cil for Har­mon­i­sa­tion’s (ICH) over­ar­ch­ing Good Clin­i­cal Prac­tice (GCP) guid­ance, last up­dat­ed in 2016.

GCPs are the in­ter­na­tion­al­ly-rec­og­nized eth­i­cal, sci­en­tif­ic and qual­i­ty stan­dards that hu­man tri­als should ad­here to, mak­ing any up­dates to the ICH guid­ance close­ly watched. In this lat­est round of re­forms, the guid­ance of­fers new rec­om­men­da­tions ap­plic­a­ble to a broad range of tri­als in­clud­ing those with in­no­v­a­tive de­sign el­e­ments or dig­i­tal health tech­nolo­gies.

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