Jan 28, 2020: This is a pivotal time in the field of the gene therapy as the FDA continues its efforts in order to support innovators developing new medical products for Americans and others around the world. Up till now, the FDA has approved four gene therapy products, which insert new genetic material into the patient’s cells.
The agency think likely for many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area, this will provide patients and providers with increased therapeutic choices.
In that spirit, today, the FDA is announcing the release of the number of important policies: six final guidances on the gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of the Gene Therapy Products Under the Orphan Drug Regulations
.One of the most important steps the FDA can take to support safe innovation in this field is to create policies that can provide product developers with the meaningful guidance to answer critical questions as they research and design their gene therapy products.
Overall, these policy documents are representative of the efforts to help advance product development in the field of gene therapy.
The FDA is an agency inside the U.S. Department of Health and Human Services which protects the public health by assuring the safety, efficiency, and security of the human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
The agency also is responsible for the safety and protection of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. https://www.fda.gov/news-events/press-announcements/fda-continues-strong-support-innovation-development-gene-therapy-products
