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The Food and Drug Administration (FDA) has released a draft guidance titled, “Good Clinical Practice (GCP) E6(R3),” explaining how the...
Cortex - Life Sciences Insights
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On March 1, 2023, FDA’s Center for Drug Evaluation and Research (CDER) published a discussion paper on artificial intelligence (AI) in...
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With the mounting mental health crisis intensified by the COVID-19 pandemic, the telemental health industry has exploded in recent years....
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In the wake of FDA’s long-awaited final guidance for the regulation of Clinical Decision Support Software, many software developers and...
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Clinical Decision Support (CDS) software is an area driven by innovative technologies that is often intertwined with traditional clinical...
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President Joe Biden has issued an Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and...
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After a brief hiatus from the string of Warning Letters sent to 503B outsourcing facilities in mid- to late 2021, on June 7, 2022, FDA...
