FDA: Time to advance manufacturing

8 September 2020

By Dr Nicola Davies

Advanced manufacturing uses innovative manufacturing technologies to address medication shortages, improve drug quality, and accelerate time to market. Many outdated manufacturing processes are still being used in the manufacture of modern medical products, increasing the risk of product shortages, inflating the scale of production and thus product costs, and decreasing resilience to disruption during public health emergencies.

The US Food and Drug Administration has recently declared its commitment to fostering innovation and adopting advanced manufacturing technologies,1 with the Trump administration dedicating $58 million in its fiscal year 2019 budget to enable the agency to develop a science-based regulatory framework to progress this transition.2 This article presents the FDA’s strategies to advance towards a more modern approach to manufacturing.

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