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New approach could eliminate minor differences among authorities, enabling pharmaceutical manufacturing processes to become truly global.
FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.
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Nearly 500 shipments of illegal and unapproved prescription drugs and combination medical devices were seized at US borders thanks to Operation Broadsword.
Biogen’s “recipe-driven qualification” knowledge management program standardizes data collection and reporting in the laboratory, with efficiency gains of 66%.
The SARS-CoV-2 outbreak has the federal government working not only on a vaccine candidate specifically targeted at the novel coronavirus but also thinking more broadly about ways to head off future potential pandemics with emerging pathogens.
Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.
The FDA’s proposal to establish a separate review path for novel excipients draws industry plaudits and requests for fine-tuning.
Foundry for American Biotechnology to provide labs and help commercialize technology to protect against and respond to health security threats; first project focuses on validation of devices to make medicines on-site.
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