Regulatory

TcLand Expression is pursuing an active clinical development strategy in Europe and the USA in order to meet the EC and FDA regulatory requirements for the development of biomarkers.

Prior to granting regulatory approval (Pre-Market Approval, or pre-market notification [510(k)] in the USA; CE Mark in Europe), the safety and effectiveness of our tests are studied in the intended patient population so as to provide valid scientific and medical evidence.

These steps require appropriate ethical committee and local health authority approvals in the corresponding regions or countries for the conduct of such clinical investigations, in accordance with the ICH Good Clinical Practice Guidelines E6.

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