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Conducting Remote Regulatory Assessments Questions and Answers

US FDA says reorganization a tough slog in tight budgetary environment

The U.S. FDA is undergoing a significant overhaul of operations which is designed in part to make the agency’s Office of Regulatory Affairs (ORA) more efficient and less obtrusive to product centers, such as the Center for Devices and Radiological Health.

FDA announces voluntary recall of tianeptine products aka station station heroin

A company selling tianeptine – aka “gas station heroin” – has agreed to voluntarily recall all lots of three of its products after the Food and Drug Administration sent a letter to retailers, including convenience stores and gas stations, FDA announced.

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