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NZ Gov to Repeal Therapeutic Products Act

NZ Gov to Repeal Therapeutic Products Act
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Taking a Look at The FDA s Regulatory Agenda

The Biden Administration released the Fall 2022 Unified Agenda of Regulatory and Deregulatory Actions published by the Office of Information and Regulatory Affairs. The FDA lists 74 short term actions and 47 proposed rulemakings and 27 final rulemakings in the current edition.

Confidence USA ordered to close after decade of inspection failures

Confidence USA ordered to close after decade of inspection failures ©Getty Images - serggn Confidence USA Inc, a dietary supplement manufacturer, has been ordered to close after a history of alleged non-compliance with cGMP regulations that extends over a decade. Late last week, Judge Edward R. Korman of the US District Court for the Eastern District of New York entered an order of permanent injunction at the behest of the US Food and Drug Administration against the Long Island, NY-based company, its president Helen Chian and general manager and founder Jim Chao. The permanent injunction requires the defendants to cease manufacturing, holding, or distributing dietary supplements until they comply with FDA stipulations.  While it’s possible to return to operations after such an injunction, few companies have done so.

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