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# CDER Study Verifies Continuous Manufacturing Benefits
- URL: https://www.fdaweb.com/cder-study-verifies-continuous-manufacturing-benefits/
- Published: 2022-05-05T12:00:00.000Z
- Updated: 2026-09-14T17:43:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151746

A CDER self-audit of continuous manufacturing regulatory submissions and outcomes identified no substantial barriers associated with common regulatory interactions related to the implementation of continuous manufacturing as compared to batch manufacturing. A study [report](https://doi.org/10.1016/j.ijpharm.2022.121778?ref=fdaweb.com) in the *International Journal of Pharmaceutics*, also says there are potential regulatory and clear economic advantages observed for applications to FDA using continuous manufacturing. “Products of continuous manufacturing tended to reach the market sooner after regulatory filing,” the 11 CDER authors say, “translating to earlier patient access to medicines and a potential $171-$537 million in early revenue benefit.”

The study says the potential benefits of continuous manufacturing include improved product quality, reduced waste, lower costs, and increased manufacturing flexibility and agility.

The self-audit of U.S. regulatory submissions examined the outcomes, at approval and during the product lifecycle, of continuous manufacturing applications as compared to traditional batch applications.

The article says FDA “has long championed the development and implementation advanced manufacturing technologies like continuous manufacturing for drug substances and finished drug products because of the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to fluctuations in product demand.”