New report urges overhaul of medical device approvals
The Institute of Medicine says the FDA's current approach doesn't meet its goals.

The Truth About 2011's New Drug Approvals
As many new drugs were approved in the first half of this year as in all of last. That's good news, right? Maybe not.The Food and Drug Administration has approved 20 new medicines in the first half of this year, one short of of the total for all of 2010. Janet Woodcock, head of the FDA division that handles new drug approvals, said in Congressional testimony that this shows the FDA is not ...

FDA Issues New Guidance for 510(K) Medical Device Approvals
The U.S. Food and Drug Administration (FDA) just issued new draft guidance for 510(K) device approvals. The draft guidance clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission. Congress gave the FDA authority over medical devices in 1976 and allowed it a quick review process for new devices it [...]