FDA

Notable 2024 Healthcare Innovations

In 2024, the healthcare industry witnessed groundbreaking innovations that redefined patient care, medical research, and technological integration. Here we explore some of the most impactful healthcare breakthroughs of 2024, shedding light on how they are shaping the future of medicine.

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A Sea-Change is Coming in How Laboratory-Developed Tests are Regulated – Is your Lab Ready?

By Inga Rose & and Aaron Schlum – On May 6, FDA published a final rule that will change the way laboratory-developed tests are regulated. The rule phases out the agency’s general policy of “enforcement discretion” and mandates that, across five stages within the next four years, LDTs will be beholden to the same regulatory requirements as in vitro diagnostics.



FDA Promotes Clinical Trial Innovation

By Hilary Marston MD MPH & Kevin Bugin PhD – Breakthroughs in science and technology are advancing innovation in more areas of medicine, providing novel treatment options for patients. The scientific community has a deepening understanding of disease and human biology, and of the enormous potential afforded through new technologies.



Realizing the Promise of Real-World Evidence

By Robert Califf – What we now call real-world data (RWD) have been used for years in medical product development to inform study design and endpoint selection, identify potential participants and trial sites, and assess safety in the post-marketing setting.