Newsletter - July 14, 2023
Trends in FDA Approval of Breakthrough Devices
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...Read More
FDA Advise on Risk Assessment for Manufacturing Changes for HCT Products
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...Read More
Trends in FDA Approval of Breakthrough Devices
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...Read More
FDA Advise on Risk Assessment for Manufacturing Changes for HCT Products
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...Read More
