In September 2016, the FDA hosted a public hearing to review draft guidances pertaining to the FDA regulation of stem cells. It addressed the regulation of human cell and tissue-based products (HCT/Ps), defined by the FDA in § 1271.3(d) as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”
FDA Draft Guidance for HCT/Ps
In this article:
- FDA Regulations on Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
- FDA Guidance Documents
- FDA Draft for Manipulating HCT/Ps
- Additional FDA Guidelines for Medicine with HCT/Ps
Since that time, we have not heard from the FDA about how they have integrated the public feedback. [Read more…]
Leiden and Oss, The Netherlands, May 30th, 2017 – Pluriomics and Pivot Park Screening Centre announced a collaboration to improve Pluriomics’ cardiovascular drug discovery service offerings and to expand Pivot Park Screening Centre’s knowledge about new and innovative assay technologies used to accelerate drug discoveries. Giving Pluriomics access to the Screening Centre’s ultra High Throughput Screening (uHTS) capability, this collaboration will serve Pluriomics’ mission which is to contribute to the efficiency of the drug discovery and development process by reducing the development length, costs and late stage attrition of novel drug candidates.
