Provide the Food and Drug Administration Feedback on Distributed and Point-of-Care Manufacturing; Comments Due December 13, 2022
The U.S. Food and Drug Administration (FDA) is seeking input on distributed manufacturing (DM) and point-of-care (POC) manufacturing because of their potential to enable rapid, localized, and timely response to demands for therapies. Although no such manufacturing is currently approved by the FDA, the agency has already seen interest by several technology developers. The FDA Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER) formed the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative to determine whether an application using an advanced manufacturing technology can fit within the existing regulatory framework. Findings from this initiative would inform potential future policy development.
The FDA has identified areas of consideration in a discussion paper titled, Distributed Manufacturing and Point-of-Care Manufacturing of Drugs, and is asking for public feedback on key questions identified in the paper, such as:
- 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?
Stakeholders can provide input in various ways:
- Attend the public workshop on November 14-16.
- Submit comments to the public docket under docket number FDA-2022-N-2316.
- If developing direct manufacturing or point-of-care technology, contact CDER’s Emerging Technology Program at CDER-ETT@fda.hhs.gov or CBER’s Advanced Technologies Team at Biologics@fda.hhs.gov (add “CATT” to the subject line).