FDA reevaluating vaginal mesh implants
The FDA says there is little evidence that the implants, used to strengthen vaginal tissue, improve pelvic organ prolapse and warns that patients are exposed to a number of serious risks. The agency releases an updated advisory after a rise in reported complications, and is calling for a reassessment. WASHINGTON Following a spike in reported complications, the Food and Drug Administration ...

FDA drug approval rate for 2011 likely to exceed 2010 rate (Morning Read)
If you feel like you've been reading a lot about FDA drug approvals this year, it's because you have. In a testimony before the House Energy and Commerce's health committee last week, the head of the FDA's drug division reported that the FDA approved 20 new drugs already this year, compared to 21 in all of 2010, and is on par to exceed approval numbers for the past several years.

Minnesota lawmakers critique FDA medical devices policy over IDEs
The medical device industry s favorite Congressional delegation has fired another salvo at the FDA approvals process. Minnesota s entire Congressional delegation sent a letter Thursday to U.S. Food and Drug Administration Commissioner Margaret Hamburg saying they are very concerned about the Investigational Device Exemption (IDE) review process. The delegation cites some of the industry s ...