FDA moves toward clearer, faster biotech regulatory action

The Food and Drug Administration announced plans Tuesday to clarify and speed up the regulatory path for new gene-edited traits in both plants and animals. In its new Plant and Animal Biotechnology Innovation Action Plan, the agency declared broadly that it will “clarify our science-and-risk-based approach for product developers; avoid unnecessary barriers to future innovation in plant and animal biotechnology; and advance safety and our public health mission.”The initiative is focused on facilitating regulatory approvals for animal biotech advances and products.