If the US FDA could track production, it could anticipate shortages – and national security threats from countries like China.

FDA is hoping that by laying out its expectations for continuous manufacturing, applicants will feel more comfortable about adopting such approaches instead of sticking with conventional batch methods.

Regulators and industry officials agree that despite efforts to spur development of continuous manufacturing, uptake has been slow globally. FDA still is on learning curve and acknowledges a knowledge gap around some of the higher order principles associated with continuous manufacturing.