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August 01, 2008 (Vol. 28, No. 14)

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. ...

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