Last week, advice was released by the US Food and Drug Administration (FDA) providing guidance for drug manufacturers wishing to engage with the agency program that is intended to develop the use of emerging technologies, such as continuous manufacturing or 3D printing.
The FDA guidance provides recommendations to manufacturers wanting to participate in a programme to submit chemistry, manufacturing and controls (CMC) information that includes the use of emerging technologies within its marketing authorisation applications. This opportunity is available for use with: investigational new drug applications (IND), original or supplemental drug applications (NDA), abbreviated new drug applications (ANDA) or biologic licence applications (BLA), or application-associated drug master files (DMF) reviewed by the Center for Drug Evaluation and where the technology meets other criteria described within the guidance. Previous draft guidance from 2015, which is replaced by this document, did not include submissions of DMF’s. This program does not cover products reviewed by the Center for Biologics Evaluation and Research (CBER).
The FDA has been concerned that medicine manufactures have been reluctant to utilise new technologies in case this leads to delays in marketing authorisation approvals. They recommend that with early engagement through this program, they hope that potential issues may be identified and resolved in advance of any submission being made. To be eligible to participate in the FDA program, there must be at least one technological element with which the agency has limited experience.
“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.
As well as the final guidance, the FDA has published a new manual of policies and procedures outlining the roles and responsibilities of their team when reviewing submissions or providing advice to sponsors on emerging technologies.
The full FDA Guidance document ‘Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry’, is available here.