FDA Draft Guidance on Gene Therapy Innovations Highlights Intellectual Property Challenges in Biotech Sector
In the ever-evolving landscape of biotech innovation, a recent draft guidance from the U.S. Food and Drug Administration (FDA) has captured attention. The guidance, titled “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing,” illustrates strategies for pharmaceutical sponsors to harness existing scientific knowledge to streamline the development of gene…