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FDA’s quality metrics initiative emerges from hibernation with a two-part feedback program and a site visit program. The agency plans to collect feedback on quality metrics in certain meetings conducted during the application process – and in a pilot program. Agency staff also plan to visit firms to learn how they use quality metrics.
Latest From Manufacturing
Capacity shortages are looming for manufacturers wanting to develop and commercialize cell and gene therapy products over the next five years, an industry survey shows. The key finding: these firms should quickly build and staff the manufacturing facilities they will need.
Don’t do anything rash to avoid US tariffs on drug products, ingredients and supplies from China, consultants advise. It would be better to just wait to see if the tariff war blows over.
FDA’s latest drug shortages task force aims to encourage investment in the reliable manufacture of generic sterile injectables that are fundamental to the practice of medicine. While the agency’s first task force continues to work with industry to avert shortages, the second will strike at underlying structural issues that cause persistent shortages of these critical medicines.
New draft document addresses issues with applying quality-by-design to gene therapies, accommodating the Common Technical Document format, as well as drug substance, cell bank and contract manufacturing issues. US FDA's Denise Gavin offers insights on agency thinking at gene therapy conference.
Sanofi is working on technical improvements after its Mourenx site in southwest France was found to be emitting illegally high levels of solvents. Production at the site is on hold.
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