Drugs

Input Sought on Advanced Manufacturing Paper

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 “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. Additionally, FDA says manufacturers developing DM and POC technology can contact (email) CDER’s Emerging Technology Program at CDER-ETT@fda.hhs.gov or CBER’s Advanced Technologies Team at Industry.Biologics@fda.hhs.gov (add “CATT” to the subject line).

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome