The new FDA commissioner, Dr. Robert M. Califf, says he supports a new surveillance program for medical devices that relies on data. Read more
It was an interesting year for legal issues surrounding pharmaceutical drugs and medical devices in 2014. This litigation covered the waterfront, ranging from “free speech” arguments under t... Read more
The U.S. Food and Drug Administration (FDA) recently announced a new program to speed up development and approval of medical devices. In the early 1990s, Congress passed the Prescription Dru... Read more
In a related matter, the FDA has issued draft guidance in an effort to clarify when medical devices that were approved through the 510(k) process, but later changed, updated or otherwise mod... Read more
The Institute of Medicine (IOM), one of the four agencies that comprise the National Academies, has called on the U.S. Food and Drug Administration to overhaul the 35-year-old 510(k) approva... Read more
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