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Zdrowie i gospodarka · 09/01/2007

In Vitro Diagnostic Multivariate Index Assays; Public Meeting

The Food and Drug Administration (FDA) is announcing a public meeting on In Vitro Diagnostic Multivariate Index Assays. The meeting is intended to provide a public forum during which FDA will hear presentations and comments from interested stakeholders regarding the draft guidance entitled "Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays." This draft guidance is intended to provide clarification on FDA's approach to regulation of in vitro diagnostic multivariate index assays. FDA is seeking comments on this draft guidance.

Source: Federal Register — Food and Drug AdministrationOpen original release →