FDA Finalizes Emerging Drug Manufacturing Technology Guidance

The agency sets expectations for the future of small and large molecule drug manufacturing.

Setting expectations and offering advice on the application of emerging technologies, the FDA issued a final guidance to the pharmaceutical industry as part of its ongoing effort to promote the integration of novel technologies into pharmaceutical drug processing and manufacturing.

The agency’s “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization” provides final guidance to companies looking to participate in the FDA’s Emerging Technology Program. The guidance steers the industry to consider implementing a broad range of new technologies and methodologies, including continuous manufacturing (CM) of small and large molecule drugs and technologies like robotic, aseptic fillinga major eliminator of contamination and subsequent drug shortages.

In its Notice to the Federal Register, FDA regulators said that supporting and enabling pharmaceutical innovation and modernization is part of the agency's mission to protect and promote the public health. “Issues in pharmaceutical manufacturing have the potential to significantly impact patient care, as failures in quality may result in product recalls and harm to patients,the introduction reads.

The agency also commented on issues in implementation, noting that equipment or manufacturing problems are a major factor leading to disruptions in drug supply. Accelerating the adoption of advanced manufacturing technology may lead to a more capable, reliable infrastructure that delivers safer more effective drugs without errors, noted the guidance. “Encouraging development of emerging technology may lead to pharmaceutical innovation and modernization, such as a more robust drug product design and improved manufacturing with better process control, thereby leading to improved product quality and availability throughout a product's lifecycle,” it continues.

A key element of the program allows pharmaceutical companies to submit questions and similar proposals regarding the specific use of an emerging technology to the relevant group within the FDA Emerging Technology Team (ETT), prior to regulatory submission. Regulators said the ETT will work in partnership with appropriate pharmaceutical quality offices and other cross-functional teams within the agency to evaluate emerging technology submissions.


Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.