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FDA in Brief: FDA issues guidance to help advance novel technology to improve the reliability and safety and help lower the cost of pharmaceutical manufacturing

For Immediate Release: Sept. 28, 2017

Media Inquiries

  Lauren Smith Dyer

“We’re at an inflection point in the practice of medicine, not only in terms of novel therapies, but also when it comes to the advanced technology being used to manufacture these products. In recent years, we’ve seen significant advances in the modernization of drug manufacturing, including shifts to continuous manufacturing and the first 3D printed drug. These advancements have led to improved products for patients and consumers and the opportunity to have a more stable and lower cost supply chain,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA is committed to continuing to foster advances in innovative pharmaceutical manufacturing, which ultimately has the potential to improve drug quality and safety.”

Incorporating promising emerging and novel technologies into the drug manufacturing process is critically important for maximizing quality and minimizing manufacturing issues. Modernizing manufacturing technology can lead to a better product design and a more robust manufacturing process with fewer interruptions in production, fewer product failures, and greater assurance that the drug products will provide their expected clinical performance.

The FDA is issuing a final guidance for industry, “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization ,” which provides recommendations to companies that are interested in participating in the FDA’s Emerging Technology Program. The program promotes the adoption of innovative approaches to pharmaceutical manufacturing and product design and provides a route for companies to engage with the FDA early, prior to regulatory submission, to submit questions and proposals regarding the use of specific emerging technologies. The scope of the program focuses on innovative and novel technologies that have the potential to improve drug product safety, identity, strength, quality and purity. The FDA has found that early engagement enables the identification and resolution of potential challenges concerning the implementation of emerging technologies.

For More Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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