Cartilage repair and replacement in the knee: a regulatory perspective
| Autor: | J. Terrig Thomas, Sylva J. Krizan, Elizabeth L. Frank, Bruce S. Schneider |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Cartilage
Articular Biomedical Research Knee Joint Tissue Engineering business.industry Cartilage Biocompatible Materials Bioengineering Bioinformatics Biocompatible material Knee cartilage medicine.anatomical_structure Tissue engineering Drug Discovery medicine Animals Humans Cartilage repair business Biotechnology |
| Zdroj: | Trends in Biotechnology. 31:665-667 |
| ISSN: | 0167-7799 |
| DOI: | 10.1016/j.tibtech.2013.08.003 |
| Popis: | The number of investigational knee cartilage repair or replacement product submissions (hereafter referred to as cartilage products) received by the FDA is increasing. This trend may reflect the rise in cartilage repair publications and active product development (Figure 1). To describe its current thinking on cartilage products, the FDA recently finalized guidance entitled ‘Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage’. This article provides an overview of cartilage product regulation and the Cartilage Guidance document. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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