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Tissue Product or 510(k)/BLA? An overview of the FDA Regulations
In the world of biologics, understanding how the FDA classifies human-derived products is crucial. Whether a product is regulated as a ...
Amniotic Essence and Exosome Lore: FDA's Position We Explore
In recent years, the FDA has increased scrutiny on products derived from exosomes and amniotic fluid due to concerns about ...
Revisiting Demineralized Bone Matrix (DBM): Is This Workhorse Biologic Underutilized in Spine Surgery Compared to Synthetics and Other Allografts?
Revisiting Demineralized Bone Matrix (DBM): Is This Workhorse Biologic Underutilized in Spine Surgery Compared to Synthetics and Other...
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