FDA preps for a new and flex­i­ble ap­proach to genome edit­ing in an­i­mals

With the use of CRISPR pro­lif­er­at­ing and gene dri­ves on the hori­zon in the US, the FDA said that it’s now look­ing at a risk-based ap­proach to reg­u­lat­ing the gene edit­ing of an­i­mals.

As part of that ap­proach the agency is es­tab­lish­ing a new pi­lot pro­gram, known as the Vet­eri­nary In­no­va­tion Pro­gram (VIP). It’s charged with pro­vid­ing tech­ni­cal and pro­gram­mat­ic as­sis­tance to de­vel­op­ers seek­ing FDA ap­proval of in­ten­tion­al­ly al­tered ge­nom­ic DNA in an­i­mals and an­i­mal cells, tis­sues and cell- or tis­sue-based prod­ucts that pro­vide a ben­e­fit to hu­man health, an­i­mal health, an­i­mal well-be­ing or food pro­duc­tion.

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