Day: July 13, 2023

Some manufacturing changes could affect the biological properties of human cellular and tissue-based products (HCTPs) to an extent that may require a new IND or a BLA supplement. Unlike drug products, HCTPs are manufactured with limited information on several key aspects of process and product characterization lending them to higher risk when changes are made. … Read more

Since its inception about 5 years ago, FDA’s Breakthrough Device Program has been involved in 67 new device approvals out of about 700 devices designated as breakthrough devices. A review of the devices designated as breakthrough and approved via this pathway indicates a few interesting trends for this program such the indications for which FDA’s … Read more