The US Food and Drug Administration (FDA) this week reiterated its plan to issue draft guidance spelling out how it intends to regulate distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs and biologics. FDA expects that issuing such guidance may clear up regulatory ambiguities and spur the adoption of these technologies.
The plan was set out in a Center for Drug Evaluation (CDER) report summarizing stakeholder feedback on an October 2022 discussion paper on DM and POC manufacturing (RELATED: FDA releases discussion paper on distributed and point-of-care manufacturing, Regulatory Focus 14 October 2022).
The impending draft guidance was included in the agency’s semiannual agenda, published in July (RELATED: Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda, Regulatory Focus, 27 July 2023)…
