Break

Over the past decade, there has been substantial progress towards modernizing pharmaceutical manufacturing. However, pharmaceutical manufacturing continues to confront a number of challenges, which result in unacceptably high occurrence of product quality issues. Nearly two thirds of all drug shortages relate to quality issues surrounding product manufacturing or facilities. These quality issues expose patients to unnecessary risk and negatively impact public health. Working with industry to encourage the modernization of pharmaceutical manufacturing technology is a mutually beneficial approach to increase manufacturing efficiency, improve overall drug quality, avoid shortages, and prepare for future regulatory challenges.

To encourage the adoption of innovative approaches in pharmaceutical manufacturing and to prepare for reviews and inspections involving technology for which there is little experience, the Agency established the Emerging Technology Program. This program features a cross-functional Emerging Technology Team (ETT) which works directly with industry to identify and resolve potential scientific and policy issues that may impact technologies new to the pharmaceutical industry. In a relatively short period of time, the Emerging Technology Program has facilitated the approvals of the first 3D-printed drug product, the first drug product made via continuous manufacturing, and the first switch to a continuous manufacturing process for an approved drug product.

Advancements in regulatory science are essential to FDA’s mission and enable the ETT to issue clear recommendations to sponsors about the risks and benefits of products that involve new technologies. FDA’s research program aims to address any knowledge and experience gaps to support these needed improvements. The knowledge gained from the internal and sponsored research will inform policy, review, and inspection activities, ensuring that FDA regulatory policies reflect state-of-the-art manufacturing science.

In this talk, FDA’s emerging technology program is described including a summary of industry interactions and observed trends. FDA’s manufacturing science research programs are highlighted e.g. continuous manufacturing, 3D printing, and process modeling to demonstrate how advances in regulatory science support the emerging technology program.