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 1. Home
 2. Drugs
 3. Distributed Manufacturing and Point-of-Care Manufacturing of Drugs |
    Discussion Paper

 1. Drugs


DISTRIBUTED MANUFACTURING AND POINT-OF-CARE MANUFACTURING OF DRUGS | DISCUSSION
PAPER

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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


 

Distributed Manufacturing and Point-of-Care Manufacturing of Drugs (PDF - 13 MB)

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.

Submit Comments


   CONTENT CURRENT AS OF:
   
   10/18/2022


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