Regulatory Focus™ > News Articles > FDA Finalizes Guidance on Emerging Manufacturing Tech Program

FDA Finalizes Guidance on Emerging Manufacturing Tech Program

Posted 28 September 2017 | By Michael Mezher 

FDA Finalizes Guidance on Emerging Manufacturing Tech Program

The US Food and Drug Administration (FDA) on Thursday finalized its guidance detailing how drugmakers can participate in the agency's program to advance the use of emerging manufacturing technologies, such as continuous manufacturing or 3D printing.

"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.

Despite the promise of these new technologies, FDA says drugmakers are often hesitant to embrace new manufacturing technologies out of concern that using such technologies could lead to delays if FDA reviewers are not up to speed on them.

But through early engagement in the emerging technology program, FDA says it hopes to identify and resolve issues related to new technologies before a regulatory submission is made.

In a blog post earlier this month, Michael Kopcha, director of FDA's Office of Pharmaceutical Quality, pointed to Vertex's cystic fibrosis drug Orkambi (lumacaftor/ivacaftor) and Janssen's HIV treatment Prezista (darunavir) as examples of companies successfully using continuous manufacturing after engaging with FDA's emerging technology team.

To take part in the program, FDA says a submission must contain at least one technological element that the agency has limited experience with. The agency also specifies that the program is aimed at technologies that are not only novel or innovative, but have the potential to improve a drug's safety, identity, strength, quality or purity.

While the final guidance is largely similar to the draft version released in 2015, there are several notable changes, such as including drug master files (DMFs) in the list of submissions that are eligible for inclusion.

The final guidance also specifies that FDA's emerging technology team will work in partnership with the Office of Compliance and Office of Regulatory Affairs "to conduct review, on-site evaluation, and make the final quality recommendations regarding the potential approval of submissions in the program."

Additionally, the final guidance clarifies that products reviewed by the Center for Biologics Evaluation and Research (CBER) are not eligible for the program.

Alongside the final guidance, FDA also published a new manual of policies and procedures clarifying the roles and responsibilities of staff in reviewing submissions to the program or providing input to sponsors on emerging technologies identified in other regulatory submissions.

Guidance, MAPP


© 2022 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.