Regulatory Pathways for Molecular Dx – Detailing the Various Options Available and What Each Requires

Companies focusing on IVDs are regularly confronted with the need to make critical strategic decisions regarding how they commercialize their test. The novelty of the technology and its intended use are just some of the factors that govern what kind of application a firm can file to gain approval.

With the overlap of pharmaceutical R&D and diagnostic development becoming greater, drug companies must be aware of these options as well. The wrong decision can have a dramatic effect on the time to market, cost, and commercial success.

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