FDA on Gene-Edited Plants and Animals: “We’ve Got This”

By Ricardo Carvajal — To the possible chagrin of those who think that FDA lacks jurisdiction over gene-editing of plants and animals, the Agency announced a Plant and Animal Biotechnology Innovation Action Plan that lays out actions the Agency is taking to help harness the potential benefits of the technology while guarding against its potential risks (for a primer on gene editing and FDA’s regulatory framework, see here). Although additional guidance on regulation of plant biotechnology products is under development, the thrust of the Action Plan appears geared toward animal biotechnology products – a category potentially at risk of withering in the face of uncertainty as to how FDA can apply its new animal drug framework without imposing unnecessarily onerous regulatory burdens. The Action Plan promises to address that uncertainty in part through the issuance of guidance documents. One document is expected to lay out a regulatory approach…

Read more detail on Recent Products Liability posts –

This entry was posted in Products Liability and tagged , , , , . Bookmark the permalink.

Leave a Reply