GAO: FDA’s Drug Oversight Requires Broad Reform

The FDA should protect the public more effectively by improving its oversight of drugs and biologics, according to a government report that added the agency to a list of operations in need of transformation or at risk for mismanagement. New laws, complex medical products submitted for approval and the globalization of the drug industry are testing the FDA’s ability to ensure the safety and effectiveness of drugs, biologics and devices, the report produced by the Government Accountability Office (GAO) says.
Drug Industry Daily