MedPage Today September 26, 2022
David Nash, MD, MBA, FACP

— Rapid development risks getting ahead of governance structures

It’s no secret that scientific and technologic innovation has been accelerating at breakneck speed, and nowhere is the evidence more pronounced than in the biomedical technology sector. How, when, and by whom are these innovations and their offspring being monitored, regulated, and vetted for safety and effectiveness?

Traditionally, federal agencies such as the FDA, CMS, and the Federal Trade Commission have played a pivotal role in evaluating pharmaceuticals and medical technologies. By means of assessing analytical validity, clinical validity, and clinical utility, the number of new entries into the marketplace has been limited and the quality of new products has been ensured.

The rapidly evolving nature of today’s biomedical technologies, coupled...

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Topics: Biotechnology, CMS, FDA, Govt Agencies, Medical Devices, Pharma / Biotech, Precision Medicine, Regulations
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