For years, Congress has been urged by a growing coalition of state life sciences associations, patient groups, and other stakeholders, to enact legislation that will modernize the Food & Drug Administration’s (FDA) regulation of diagnostic tests, giving the agency the authority, the framework and the resources to balance proper oversight with advancement of innovation. Colorado BioScience Association (CBSA) and our national partners continue to strongly advocate for a flexible, risk-based regulatory system that ensures timely patient access to accurate and reliable cutting-edge diagnostic technologies.
Despite headwinds during the last Congress when important riders including the Verifying Accurate Leading-Edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act were left out of the final package to reauthorize FDA User Fee Programs, lawmakers are pushing again for creation of a program to modernize FDA regulation of diagnostic tests. The VALID Act of 2023, bipartisan legislation introduced by Reps. Larry…
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