Axiofill Maker MiMedx Disputes FDA Warning Letter

In response to an FDA warning letter about its placental-derived tissue product Axiofill, MiMedx Group defended its position that Axiofill is not a biologic drug and therefore not subject to additional oversight.

In its warning letter, the FDA contends that Axiofill, a placental collagen treatment for damaged tissue, is subject to two regulations — one for human cell, tissue, or cellular or tissue-based product (HCT/P) and additional regulations as a biologic drug, including appropriate premarket review.

MiMedx has stated that Axiofill was developed and is manufactured to comply with the requirements for an HCT/P and not as a biologic. The company says the drug is composed solely of human placenta and is used only to replace or supplement damaged tissue.

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