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# FDA Encouraging ‘Advanced Manufacturing’
- URL: https://www.fdaweb.com/fda-encouraging-advanced-manufacturing/
- Published: 2020-08-04T12:00:00.000Z
- Updated: 2026-09-14T16:23:41.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5147352

FDA commissioner **Stephen Hahn** and deputy commissioner for medical and scientific affairs **Anand Shah** say the agency has sought to encourage and facilitate the adoption of “advanced manufacturing,” which they say refers to new and emerging approaches for producing medical technologies. Writing in an *FDA Voices* post, Hahn and Shah say that advanced manufacturing approaches apply to different medical product areas, including continuous manufacturing for drugs and 3D printing for patient-specific medical devices.

The post says that over the past decade, FDA has made strategic, forward-looking investments in personnel, policies, and processes to create a clear regulatory pathway for innovators across drug, biologics, and medical devices. They say FDA: 

- recognized that innovators seeking to adopt advanced manufacturing technologies may be concerned about the technical and regulatory challenges associated with transitioning away from their existing platforms;
- recognized that policy must keep pace with innovation; and
- supported research and partnerships that expand the knowledge base for advanced manufacturing.

The authors conclude that the Covid-19 pandemic “has shown how conventional manufacturing practices and predominantly international supply chains may be a liability for America’s emergency response efforts.”