FDA finds drug research firm faked samples, documents
WASHINGTON (Reuters) - Drug companies that had medicines tested by contractor Cetero Research might have to reevaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples.

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The U.S. Food and Drug Administration (FDA) just issued new draft guidance for 510(K) device approvals. The draft guidance clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.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