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.

biotech manufacturing
• Source: Shutterstock

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.

More from Manufacturing

Over The Counter: What To Expect From The 61st AESGP Annual Meeting, With Jurate Švarcaite

 
• 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 Consumer Health Expands North America And LATAM Supply Capacity

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.

‘We All Have To Start Somewhere’: How Retailers Are Shaping Perrigo’s Climate Ambitions

 
• 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.

Stada Bolsters OTC Production With Romanian Site

 
• 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

Pink Sheet Podcast: Understanding The Impact Of The Latest HHS Layoffs On The US FDA

 

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.

EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.