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The U.S. Food and Drug Administration (FDA) just issued new draft guidance for 510(K) device approvals. The draft guidance clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.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 [...]

FDA, International Counterparts Report Progress on Drug Inspection Collaboration
SILVER SPRING, Md., Aug. 2, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration, together with its European and Australian counterparts, today released two reports detailing the results of pilot programs focused on increasing international regulatory collaboration among the agencies so that drug quality and safety can be enhanced globally.

Resistant Salmonella Strain Resurfaces; FDA Cracks Down With New Laws
The importance of FDA and other global health agencies to seriously monitor the international food traffic network is brought to the forefront this week as a new multidrug-resistant strain of salmonella called S. Kentucky is back in major countries such as the United States, Denmark, France, England and Wales according to analysis. This particular strain has a high level of resistance to ...