clinicalpainadvisor.com8d
2024 Novel Drug and Biological Product Approvals
The FDA approved a wide range of therapies in 2024, including many new molecular entities and biological products.
Almost half of FDA-approved AI medical devices are not trained on real patient data, research reveals
Most notably, 226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation data. A few ...
News Medical on MSN5mon
Almost half of FDA-approved medical AI devices lack clinical validation data
Most notably, 226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation data. A few ...
FDA approved the first new kind of pain medication in 27 years. Here’s how it works
The FDA just approved a new type of pain medication, and it's a non-opioid called suzetrigine that stops body pain at its ...
JD Supra4d
FDA Dumps Trio of Device-Related Guidances Prior to Administration Change
Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...
Becker's Hospital Review15d
FDA spotlights risks in medical device supply chain
The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.
Becker's Hospital Review10d
FDA's plan to tackle medical device shortages: 4 notes
The FDA is ramping up efforts to address medical device shortages that are increasingly threatening patient care, particularly for pediatric and neonatal populations. In a Jan. 16 news release ...
medtechdive1mon
Few medical devices are designed for children. An FDA-Children’s National collaboration aims to change that.
What incentives are pediatric device developers missing? Drug developers are asked by the FDA whether their drug was also tested in the pediatric population, but the equivalent of that does not exist ...
Forbes1y
FDA Approved A New Weight Loss Drug Zepbound. Here’s What To Know And Expect
Dr. Omer Awan is a practicing physician who covers public health. CARLSBAD ... for The Washington Post via Getty Images) The FDA recently approved Zepbound, a weekly injectable drug targeted ...