Distributed Manufacturing and Point-of-Care Manufacturing of Drugs | Discussion Paper
The U.S. Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) has issued a discussion paper, Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.
About the Discussion Paper
This discussion paper presents areas associated with Distributed Manufacturing (DM) and Point-of-Care (POC) manufacturing that FDA has identified for consideration as FDA evaluates our existing risk-based regulatory framework as it applies to these technologies. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development.
The discussion paper considers relevant background, including terminology, to the FDA’s regulation of DM and POC, identifies challenges presented by DM and POC, and poses key questions to facilitate public comment. The FDA is seeking input on each of these topics and on 20 questions posed in the discussion paper.
Submitting Comments on the Discussion Paper
As part of its commitment to innovations in drug manufacturing, the FDA is sharing Distributed Manufacturing and Point-of-Care Manufacturing of Drugs for review and comment.
The FDA seeks further input from stakeholders to address these topics and questions to gather feedback from the public to inform future policy development.
The FDA encourages stakeholders to provide comments under docket number FDA-2022-N-2316. The last day to submit comments is December 13, 2022.