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These two populations differ in developmental origin: AMs mainly derive from fetal liver progenitors, whereas IMs originate from yolk sac progenitors and can be further supplemented by recruited blood monocytes ( The dynamic changes and phenotypic characteristics of these macrophage populations have been validated through single-cell RNA sequencing and flow cytometry ( 3 Macrophage polarization Macrophages, as a functionally diverse class of immune cells, exhibit high plasticity and can adapt to different tissue microenvironments to perform a wide range of functions ( 3.1 M1 macrophages M1 macrophages are primarily induced by signals such as bacterial lipopolysaccharide (LPS) and interferon- (IFN-), which activate transcriptional pathways including signal transducer and activator of transcription 1(STAT1) and NF-B to initiate and sustain a robust pro-inflammatory response ( 3.2 M2 macrophages M2 macrophages are mainly polarized under the mediation of IL-4, IL-13, and IL-10 through activation of the STAT6 signaling pathway ( M2 macrophages are not a homogeneous population but are further subdivided into M2a, M2b, M2c, and M2d subtypes based on their inducing signals and functional characteristics ( Macrophages can polarize into either pro-inflammatory M1 or anti-inflammatory M2 phenotypes in response to distinct environmental cues

For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in Instructions. Instructions: All submissions received must include the Docket No

Unlike classical neurotransmitters, its not definitively produced within neurons, lacks confirmed precursor molecules in neural tissue, and has no conclusively demonstrated direct receptor binding

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