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Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 
• By Bridget Silverman

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.

biotech manufacturing
Inconsistent regulations around the world have hindered advanced manufacturing technology adoption. • 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.

Key Takeaways

  • The US FDA draft strategy on innovative manufacturing meets a PDUFA VII commitment, builds on a 2023 public workshop and sets performance goals for communication and collaboration.

  • Stakeholders cited inconsistent international regulations as a barrier to adoption of advanced manufacturing technologies

“Global harmonization of regulatory expectations for submissions using innovative manufacturing should be prioritized,” the FDA said in the

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