Zdrowie i gospodarka · 16/04/2018

FDA Announces Draft Guidance for Streamlined In Vitro Diagnostic Submission Process in Oncology Trials

The FDA has released a draft guidance outlining an optional streamlined process for determining the risk of investigational in vitro diagnostics in oncology clinical trials, allowing for more efficient review and submission of study data.

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

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