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.
More from Manufacturing
• By
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.
• By
Perrigo's retail customers are expecting real "net zero" progress from consumer health manufacturers, which is in turn driving the firm's sustainability ambitions and expectations from their own suppliers, Perrigo’s UK ethical compliance lead Isobel Gay tells HBW Insight in this exclusive interview.
• By
Stada will ship a wide range of consumer healthcare products from its new Romanian production facility, into which the German firm has invested over €70m.
More from Pink Sheet
• By
The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
• By
A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
• By
Democrats opposed the nomination because they believe Mehmet Oz will not defend Medicaid from spending cuts. His pledge to continue lowering drug costs in Medicare and Medicaid did not offset the concerns.