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# Input Sought on Advanced Manufacturing Paper
- URL: https://www.fdaweb.com/input-sought-on-advanced-manufacturing-paper/
- Published: 2022-12-09T12:00:00.000Z
- Updated: 2026-09-14T18:09:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153368

FDA is seeking feedback on a discussion paper entitled *Distributed Manufacturing and Point-of-Care Manufacturing of Drugs* that presents areas the agency has identified for consideration while it evaluates the existing risk-based regulatory framework as it applies to those technologies. The agency says the discussion [paper](https://www.fda.gov/media/162157/download?ref=fdaweb.com) “considers relevant background, including terminology, to the FDA regulation of direct manufacturing (DM) and point-of-care (POC) manufacturing, identifies challenges presented by DM and POC, and poses key questions to facilitate public comment.”

Among areas FDA has identified for consideration include:

- How often might a DM unit move to a new location and what might an applicant report to the agency when doing so?
- What locations are envisioned for POC unit operation?
- How might a centralized quality system (i.e., at a “parent location”) ensure each manufacturing unit complies with regulatory requirements and quality standards?
- What type of business relationships are envisioned between companies developing POC manufacturing platforms and health care facilities?

Interested stakeholders can provide input to the public docket, under docket number [FDA-2022-N-2316](https://secure-web.cisco.com/1HALfNdVdIPFTDtfkTx18hQLihLsNLrqnjVA-NGMYDKLHkX040ZiAL9syEMEKq3C99dGQQ9sM3G1VJGx9DAqhmSO5uMV4c2kgp5BOD47HhsqugQ65yN4KuYl9Rljnf9zdgtm84eNrBzRXUMSqR449quf3jpMPFmfVx%5FV6HXURJcBPsTQjOC-zMBYIQF3RCEvcOdnuPpdQbrw2ajzqc%5F2ilQ/https%3A%2F%2Flnks.gd%2Fl%2FeyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDQsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjEyMDkuNjc5NDQwMDEiLCJ1cmwiOiJodHRwczovL3d3dy5yZWd1bGF0aW9ucy5nb3YvZG9jdW1lbnQvRkRBLTIwMjItTi0yMzE2LTAwMDE%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.kAOfyNiJuCk-NGfymdhh8B4ATeYQQvK9LSrZ5bY8VAo%2Fs%2F1255720147%2Fbr%2F150001826120-l?ref=fdaweb.com). Additionally, FDA says manufacturers developing DM and POC technology can contact (email) CDER’s Emerging Technology Program at [CDER-ETT@fda.hhs.gov](javascript:void%280%29;) or CBER’s Advanced Technologies Team at [Industry.Biologics@fda.hhs.gov](javascript:void%280%29;) (add “CATT” to the subject line).