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The Quality Lowdown: Valsartan Options, Supply Chain Warnings, Button Cameras

 
• By Bowman Cox

Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.

The Quality Lowdown

The crisis over the contamination of valsartan and other angiotensin II receptor blockers with carcinogenic nitrosamines continued to unfold, with the US FDA quickly approving a 17th generic version of the blood pressure medication in hopes of alleviating shortages, while a bipartisan request for a House committee staff briefing on the issue suggests there could be a legislative response on the horizon.

In the meantime, FDA criminal investigators procure some interesting equipment and services in their efforts to nab drug counterfeiters.

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