Twenty Questions: How Should The US FDA Regulate Distributed Drug Manufacturing?
What happens when manufacturing plants are moving targets? When quality systems are at once more centralized and dispersed? When plant operators are health care workers? Agency wants input before settling on the answers.
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US FDA’s OPQ Aims To Clear The Way For Further Manufacturing Technology Advances in 2023
As the agency's Office of Pharmaceutical Quality releases its annual report highlighting last year's efforts to advance distributed and point-of-care manufacturing, OPQ director Kopcha tells the Pink Sheet of plans to focus on activities advancing the use of artificial intelligence in manufacturing process control this year.
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.
Point-Of-Care Manufacturing Successfully Treats B-Cell Cancers; How Will FDA Regulate It?
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.