HHS Inspector General: FDA's Generic Review Exceeds Limits (Nasdaq)
WASHINGTON -(Dow Jones)- The Food and Drug Administration generally takes longer than the 180 days required under federal law to review generic drug applications, according to a report released Thursday.

GE Healthcares Application For Adreview (Lobenguane I 123 Injection) Accepted By The FDA For Priority Review (Medical News Today)
GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has designated for priority review the New Drug Application (NDA) for AdreView. AdreView is a molecular imaging agent for the detection of neuroendocrine tumors in pediatric and adult patients. The FDA also encouraged GE to establish an expanded access program for the agent.

Preemption Critical To Preserving Patient Access To Medical Innovation (Medical News Today)
Christopher White, executive vice president and general counsel for the Advanced Medical Technology Association (AdvaMed), released the following statement regarding today's hearing at the Senate Judiciary Committee on the Food and Drug Administration's (FDA) federal preemption authority for certain medical devices approved through the agency's pre-market approval (PMA) process.