FDA touts advanced manufacturing to address COVID shortfalls

Regulatory NewsRegulatory News | 04 August 2020 |  By 

Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the COVID-19 pandemic, Stephan Hahn, Food and Drug Administration (FDA) commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website.

“The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures,” Hahn and Shah wrote. “The FDA has established a strong regulatory foundation to support the uptake of advanced manufacturing, and COVID-19 provides the unique impetus to spur further advancement of medical manufacturing.”

They highlighted key regulations the agency has promulgated in recent years to support advanced manufacturing, specifically:
  • The Emerging Technology Program under the Center for Drug Evaluation and Research (CDER), which supports companies in developing process control measures for continuous manufacturing of drugs before submission.
  • The Advanced Technologies Team under the Center for Biologics Evaluation and Research (CBER) which supports developers by addressing technical considerations needed to create gene therapies.
  • The development of “leapfrog” guidance documents to share the agency’s thinking on emerging technologies that could be important in public health emergencies. Such anticipatory guidance supports innovators as they bring new technologies to health care.
  • Partnerships and research to expand knowledge surrounding advanced manufacturing.

Additional efforts have been undertaken during the current public health emergency, Hahn and Shah pointed out. A multiyear effort between CDER and the US Biomedical Advanced Research and Development Authority (BARDA) is looking at how continuous manufacturing processes can support the production of medical countermeasures. Further, the FDA Office of the Chief Scientist (OCS) and the Center for Devices and Radiological Health (CDRH) are working with the National Institutes of Health and the Departments of Veterans Affairs to share information on 3D printing standards to increase the stock of essential medical supplies including personal protective equipment and certain medical device parts.

FDA also is working within the International Council for Harmonization to make sure that continuous manufacturing guidances are aligned internationally to support innovators, Hahn and Shah wrote.

“Because pandemics by nature are unpredictable, our approach to manufacturing must be adaptable. Advanced manufacturing provides an approach for protecting our supply chain and improving our response capacity during crisis situations,” they concluded. “By establishing the regulatory foundation, the FDA has created a pathway for industry to continue adopting the needed improvements in manufacturing technology for the benefit of public health.”

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Tags: coronavirus, FDA, US

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