Industry Urged To Share Potential Regulatory Challenges To Decentralized Manufacturing
In a world where pharmaceuticals could be manufactured with no fixed address, industry and regulatory authorities must work together to interpret site-based compliance requirements, expert says. New concepts like the MHRA-proposed hub-and-spokes model could play key role.
You may also be interested in...
Brigham and Women's soldiered on as water gushed and microorganisms blossomed, potentially compromising sterility of injectable drugs, warning letter says. The focus was on PET drugs, but there could be implications for decentralized manufacture of personalized medicines like cell and gene therapies in health care settings.
In Cleveland and Moscow, researchers found freshly-manufactured T-cells showed faster reduction of tumor burden than cryopreserved cells, but uncertainty remains about what the clearance process for the technology will be at the US FDA.
Soon-to-be-released white papers will FRAME how FDA plans assess products manufactured with advanced technologies as part of an initiative to reduce uncertainty for sponsors.