Inconsistent international standards remain a significant hurdle to adoption of innovative manufacturing technologies, even as industry applauds the US Food and Drug Administration’s efforts to boost advanced technologies like continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment, and novel analytical methods.
Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency
Agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

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HBW Insight speaks to AESGP director general Jurate Švarcaite about what's on the agenda for the upcoming 61st AESGP Annual Meeting, which will take place in Warsaw, Poland, between 2-4 June. Highlights include the role of prevention in self-care, discussions about how regulators will ensure the competitiveness of European industry on the world stage and incoming changes to sustainability legislation.
Bayer is investing $52m in its Lerma, Mexico manufacturing site, which the firm said will enable it to increase production of key OTC brands like Aspirin and Alka-Seltzer from 100m to 140m units by 2030.
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Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.